Cidara Therapeutics Inc Annual Report 2015

Plain-text annual report

UNITED STATESSECURITIES AND EXCHANGE COMMISSIONWashington, D.C. 20549 FORM 10-K (Mark One)xxANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934For the fiscal year ended December 31, 2015ORooTRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THETRANSITION PERIOD FROM TO Commission File Number 001-36912 CIDARA THERAPEUTICS, INC(Exact name of Registrant as specified in its Charter) Delaware 46-1537286(State or Other Jurisdiction ofIncorporation or Organization) (I.R.S. EmployerIdentification No.) 6310 Nancy Ridge Drive, Suite 101San Diego, CA 92121 (858) 752-6170(Address of Principal Executive Offices) (Registrant’s Telephone Number, Including Area Code) Securities registered pursuant to Section 12(b) of the Act: Common Stock, Par Value $0.0001 Per Share; Common stock traded on the NASDAQ Global MarketSecurities registered pursuant to Section 12(g) of the Act: NoneIndicate by check mark if the Registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. YES o NO xIndicate by check mark if the Registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. YES o NO xIndicate by check mark whether the Registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. YES xNO oIndicate by check mark whether the Registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submittedand posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the Registrant was required tosubmit and post such files). YES x NO oIndicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§229.405) is not contained herein, and will not be contained, to the best ofRegistrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. xIndicate by check mark whether the Registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definition of“large accelerated filer”, “accelerated filer”, and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one): Large accelerated filer o Accelerated filer o Non-accelerated filer x (Do not check if a small reporting company) Small reporting company o Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). YES o NO xThe aggregate market value of the voting and non-voting common equity held by non-affiliates of the Registrant, based on the closing price of the shares of common stock onThe NASDAQ Global Market on June 30, 2015, was approximately $95.2 million.The number of shares of Registrant’s Common Stock outstanding as of February 29, 2016 was 13,822,747.DOCUMENTS INCORPORATED BY REFERENCEPortions of the Registrant’s definitive Proxy Statement to be filed with the Securities and Exchange Commission pursuant to Schedule 14A in connection with the registrant’s2016 Annual Meeting of Stockholders, which will be filed subsequent to the date hereof, are incorporated by reference into Part III of this Form 10-K. Such definitive proxystatement will be filed with the Securities and Exchange Commission not later than 120 days following the end of the Registrant’s fiscal year ended December 31, 2015. CIDARA THERAPEUTICS, INC. Table of Contents PagePART I Item 1. Business 3Item 1A. Risk Factors 27Item 1B. Unresolved Staff Comments 54Item 2. Properties 54Item 3. Legal Proceedings 54Item 4. Mine Safety Disclosures 54 PART II Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 55Item 6. Selected Financial Data 57Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations 58Item 7A. Quantitative and Qualitative Disclosures About Market Risk 64Item 8. Financial Statements and Supplementary Data 66Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure 82Item 9A. Controls and Procedures 82Item 9B. Other Information 82 PART III Item 10. Directors, Executive Officers and Corporate Governance 84Item 11. Executive Compensation 84Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 84Item 13. Certain Relationships and Related Transactions, and Director Independence 84Item 14. Principal Accounting Fees and Services 84 PART IV Item 15. Exhibits, Financial Statement Schedules 85 SIGNATURES CIDARA THERAPEUTICS, INC. SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTSThis Annual Report on Form 10-K contains forward-looking statements. We may, in some cases, use words such as “anticipate,” “believe,” “could,”“estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” or the negative of those terms, and similarexpressions that convey uncertainty of future events or outcomes to identify these forward-looking statements. Any statements contained hereinthat are not statements of historical facts may be deemed to be forward-looking statements. Forward-looking statements in this Annual Report onForm 10-K include, but are not limited to, statements about: ·our anticipated timing for preclinical development, regulatory submissions, commencement and completion of clinical trials and productapprovals; ·our plans to research, develop and commercialize our product candidates; ·our ability to fund our working capital requirements; ·our expected clinical trial designs and regulatory pathways; ·our ability to obtain and maintain regulatory approval of our product candidates and any related restrictions, limitations, and/or warningsin the label of an approved product candidate; ·our ability to successfully commercialize, and our expectations regarding future therapeutic and commercial potential with respect to,our product candidates; ·the size and growth potential of the markets for our product candidates, and our ability to serve those markets; ·the rate and degree of market acceptance of our products that are approved; ·our ability to develop sales and marketing capabilities, whether alone or with potential future collaborators; ·regulatory developments in the United States and foreign countries; ·the performance of our third-party suppliers and manufacturers; ·the success of competing therapies that are or may become available; ·our expectations for the attributes of our product and development candidates, including pharmaceutical properties, efficacy, safety anddosing regimens; ·our estimates of our expenses, ongoing losses, future revenue, capital requirements and our needs for or ability to obtain additionalfinancing; ·our expectation that our existing capital resources will be sufficient to enable us to complete our planned clinical trials; ·our ability to obtain and maintain intellectual property protection for our product candidates; ·our ability to use our Cloudbreak immunotherapy platform to identify development candidates, or to expand our Cloudbreakimmunotherapy platform to other areas of infective disease; ·our ability to identify and develop new product candidates; ·the potential for prophylactic use of any of our product candidates; ·our ability to retain and recruit key personnel; ·our financial performance; and ·developments and projections relating to our competitors or our industry.These forward-looking statements reflect our management’s beliefs and views with respect to future events and are based on estimates andassumptions as of the date of this Annual Report on Form 10-K and are subject to risks and uncertainties. We discuss many of these risks ingreater detail under “Risk Factors.” Moreover, we operate in a very competitive and rapidly changing environment. New risks emerge from time totime. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to whichany factor, or combination of factors, may cause actual results to differ materially from those2CIDARA THERAPEUTICS, INC. contained in any forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward-looking statements.You should read this Annual Report on Form 10-K and the documents that we reference and have filed as exhibits to the Annual Report on Form10-K completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of theforward-looking statements in this Annual Report on Form 10-K by these cautionary statements. Except as required by law, we undertake noobligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise. PART IItem 1. Business.We are a biotechnology company focused on the discovery, development and commercialization of novel anti-infectives for the treatment ofdiseases that are inadequately addressed by current standard of care therapies. We are developing a balanced pipeline of product anddevelopment candidates, with an initial focus on serious fungal infections. Our lead clinical candidates are echinocandins, a proven class ofantifungals. Our initial product portfolio comprises two formulations of our novel echinocandin, CD101. CD101 IV is a long-acting therapy for thetreatment and prevention of serious, invasive fungal infections. CD101 topical, our second product candidate, is being developed for the treatmentof vulvovaginal candidiasis, or VVC, and recurrent VVC, or RVVC, a prevalent mucosal infection. In addition, we have developed a proprietaryimmunotherapy technology platform, CloudbreakTM, which we use to create compounds designed to direct a patient’s immune cells to attack andeliminate pathogens that cause infectious disease. We are evaluating Cloudbreak candidates for the treatment of invasive fungal infectionsincluding aspergillosis, an infection caused by the fungal pathogen, Aspergillus. We are also evaluating additional opportunities to expand ourCloudbreak immunotherapy platform and have the potential to transform the treatment of infectious disease caused by a variety of fungal, bacterialand viral pathogens.We are focused on the anti-infectives market, which we believe has the following advantages for the development of innovative products: ·a high correlation between efficacy in preclinical animal models and outcomes of clinical trials; ·a regulatory environment that provides developers of anti-infectives opportunities to reduce development costs and time to market; ·an ability to commercialize anti-infective products with a focused sales and marketing organization for inpatient and outpatient settings;and ·attractive commercial opportunities in certain segments of the market, such as the estimated $3.7 billion global prescription systemicantifungal market in which there is high unmet need, high mortality rates and few new agents in development.3CIDARA THERAPEUTICS, INC. We are developing a balanced pipeline of product and development candidates as summarized in the table below. CD101 IVOur lead product candidate, CD101 IV, is a novel molecule in the echinocandin class of antifungals. We are initially developing CD101 IV for thetreatment and prevention of systemic Candida infections. These infections include candidemia and invasive candidiasis, fungal infectionsassociated with high mortality rates.The current treatment alternatives for systemic fungal infections, including polyenes, azoles and currently-approved echinocandins, havelimitations that we believe may be addressed by novel antifungals. While these drugs are largely efficacious, they may cause severe side effectsand are known to cause drug interactions that can limit their utility. Echinocandins, introduced in 2001, are increasingly recommended for thetreatment of fungal infections in the United States. In December 2015, the Infectious Diseases Society of America, or the IDSA, released newclinical guidelines that recognize the important role of echinocandins in the initial treatment of invasive fungal infections. The guidelinesrecommend a shift to echinocandins as first-line treatment for invasive candidiasis and candidemia. The approved echinocandins includecaspofungin, micafungin, and anidulafungin, and are considered both well tolerated and safe relative to other antifungal drug classes. However,they must be administered daily by IV infusion, potentially extending the hospitalization of patients for the duration of therapy and limiting their usemainly to the hospital setting. The CDC reports that certain species of Candida are becoming increasingly resistant to available antifungals, suchas the azoles and approved echinocandins.Due to its novel chemical structure, CD101 IV has a prolonged half-life, a high Cmax, or maximum concentration reached, and a high AUC, or areaunder the curve, which measures the overall drug exposure per dose. These factors are in contrast to all other echinocandins, and may allowCD101 IV to be developed as a once-weekly IV therapy with greater drug exposures over the course of therapy. We believe that thispharmacokinetic profile may overcome the limitations of the current standard of care by offering the following key benefits: ·potential to treat resistant pathogens due to CD101 IV’s higher drug exposure early in the course of therapy; ·single-agent treatment across inpatient and outpatient settings; ·shorter and less costly hospital stays, enabled by a once-weekly echinocandin; ·improved compliance for outpatients; and ·more convenient outpatient echinocandin prophylaxis regimens.In November 2015, we obtained data from our single ascending dose (SAD) study. This was a Phase 1, randomized, double-blind, placebo-controlled, dose-escalation study to determine the safety, tolerability, and pharmacokinetics of single intravenous doses of CD101 in healthysubjects. Results demonstrated that CD101 IV was well tolerated in all dose cohorts after single doses of 50 mg, 100 mg, 200 mg, and 400 mg.4CIDARA THERAPEUTICS, INC. In January 2016, we obtained data from our multiple ascending dose (MAD) Phase 1 study. This was a Phase 1, randomized, double-blind,placebo-controlled, dose-escalation study to determine the safety, tolerability, and pharmacokinetics of multiple intravenous doses of CD101 inhealthy subjects. Results demonstrated that CD101 IV was well tolerated in all dose cohorts after multiple doses of 100 mg, 200 mg, and 400 mgin up to three weeks of dosing. In the SAD and MAD studies, CD101 IV exhibited a pharmacokinetic profile consistent with preclinical data andsupportive of once-weekly dosing.We plan to initiate a Phase 2 clinical trial in candidemia in the first half of 2016. We plan to enroll approximately 90 patients with Candidabloodstream infections and expect results from this trial in the second half of 2017.The U.S Food and Drug Administration, or FDA, has granted CD101 IV designations for Orphan Drug, Qualified Infectious Disease Product, orQIDP, and Fast Track for the treatment of candidemia and invasive candidiasis. The orphan drug designation provides eligibility for seven yearsof market exclusivity in the United States upon FDA approval, a waiver from payment of user fees, an exemption from performing clinical studiesin pediatric patients, and tax credits for the cost of the clinical research. The QIDP designation, provided under the Generating AntibioticIncentives Now Act, or the GAIN Act, offers certain incentives for the development of new antibacterial or antifungal drugs, including eligibility forFast Track designation, priority review and, if approved by the FDA, eligibility for an additional five years of marketing exclusivity. Fast Trackdesignation enables more frequent interactions with the U.S. Food and Drug Administration, or the FDA, to expedite drug development andreview. The seven-year period of marketing exclusivity provided through orphan designation combined with an additional five years of marketingexclusivity provided by the QIDP designation positions CD101 IV with a total of 12 years of marketing exclusivity to be granted at the time of FDAapproval.CD101 TopicalWe are developing our second product candidate, CD101 topical, a topical formulation of CD101, for the treatment of VVC and RVVC. RVVC isdefined as the occurrence of three or more VVC infections in one year. RVVC is a painful, chronic infection afflicting four to five million women inthe United States each year. There are no therapies currently approved for RVVC. Current off-label treatments include chronic self-medication withover-the-counter topical antifungals and the use of prescription fluconazole, an oral azole. Azoles are fungistatic, which means that they slow thegrowth of, but do not kill, the fungus. In addition, azoles have poor activity against certain species of Candida that cause VVC. Therefore, azolesoften fail to prevent recurrent infections in women with RVVC. By contrast, echinocandins, including CD101, are fungicidal, which means that theykill the fungus, including all of the species of Candida that cause VVC. Unlike currently available echinocandins, which can only be administeredintravenously, CD101 is being developed for topical use due to its high solubility, stability and activity at vaginal pH values.We are planning to file our Initial New Drug, or IND, application for CD101 topical during the first half of 2016. Based on discussions with the U.S.Food and Drug Administration, or FDA, we are planning to initiate a Phase 2 multi-site clinical trial in mid-2016 to investigate the safety,tolerability, and initial efficacy of CD101 topical in women with VVC. We expect results from this trial in the first half of 2017.Cloudbreak Immunotherapy PlatformWe believe that our Cloudbreak immunotherapy platform is a fundamentally new approach for the treatment of infectious disease. The design ofthe Cloudbreak immunotherapy platform recognizes that most infectious disease is due to a temporary deficiency in the function of the immunesystem. Our Cloudbreak lead candidates are designed to address this deficiency by recruiting components of the patient’s immune system to thesite of infection, enabling more effective treatment. Similar to the way that immunotherapy has the potential to revolutionize the treatment ofcancer by redirecting the immune system to destroy cancer cells, we believe that our Cloudbreak immunotherapy platform has the potential totransform the treatment of infectious disease caused by a variety of fungal, bacterial and viral pathogens.We are currently pursuing both small and large molecule approaches for Cloudbreak. Small molecule Cloudbreak candidates consist of twomolecules that are joined by a chemical linker: a targeting moiety, or TM, that recognizes a cell surface target and an effector moiety, or EM, thatis recognized by the immune system. In many cases, we can use a commercially approved drug as the TM. By contrast, large moleculeCloudbreak candidates leverage classical targeting and immune engaging components of antibodies and antibody fragments. Large moleculeCloudbreak candidates consist of a TM, which is an antibody that binds cell-surface antigen, and an EM5CIDARA THERAPEUTICS, INC. that is recognized by the immune system. The coupling of the TM to the EM results in a bispecific molecule that can direct the immune systemspecifically to the targeted pathogen. The Cloudbreak immunotherapy platform is similar to certain cancer immunotherapies in that it uses molecules with two binding sites, one thatbinds to a cell surface target and a second that binds to specific receptors on immune cells. Our initial small and large molecule Cloudbreakcandidates recruit the innate and adaptive immune system to the site of infection, respectively. Their modular composition allows for rapidexploration of combinations of TM, EM, and linker domains, potentially enabling efficient discovery of anti-infective molecules with the desiredpotency, specificity and physical properties.We are expanding our Cloudbreak immunotherapy platform. This expansion will enable us to select development candidates that effectivelyengage the immune system and target the site of infection. We believe that our Cloudbreak immunotherapy platform has broad potentialapplications across a wide spectrum of infectious diseases, including fungal, bacterial and viral infections. We plan to select a lead Cloudbreakdevelopment candidate in 2016.Our StrategyOur objective is to become the leading biotechnology company in the discovery, development and commercialization of novel, best-in-class anti-infectives. Key elements of our strategy include: ·Rapidly advance our initial antifungal candidates to commercialization. We plan to leverage the favorable regulatory environmentfor anti-infectives to expedite the development of our product and development candidates. ·Continue to invest in our Cloudbreak immunotherapy platform. We believe that our Cloudbreak immunotherapy platform has broadpotential applications across a wide spectrum of infectious diseases, including fungal, bacterial and viral infections. We intend to pursueexpansion into these therapeutic areas and the generation of new Cloudbreak development candidates to strengthen our pipeline. Inaddition, we will continue to establish intellectual property related to this platform, its applications and development candidates. ·Commercialize products in the United States with a targeted sales force. The anti-infectives market benefits from an ability toaddress large sales opportunities with a relatively small, specialized commercial organization. We intend to build and manage a targetedsales and marketing organization to commercialize our products, if approved, in the United States, addressing the relatively small baseof well-defined customers in both the hospital and outpatient settings. In geographies outside the United States, we may seek tocollaborate with other parties to commercialize our products. ·Leverage our management’s expertise in anti-infectives to acquire or in-license complementary product candidates. In additionto our current product and development candidates, we will evaluate acquisition or in-licensing opportunities to potentially expand anddiversify our pipeline. We believe that our management team’s expertise and experience in the anti-infectives market provides ourcompany with a competitive advantage in evaluating product opportunities. Our management team will focus on opportunisticallyidentifying complementary assets that are at commercial stage or in advanced stages of clinical development.2015 DevelopmentsOn February 10, 2015, we completed a private placement of approximately $42.0 million of shares of Series B convertible stock.On April 2, 2015, our board of directors and stockholders approved a 1-for-25.4 reverse stock split of our outstanding common stock.On April 20, 2015, we completed our initial public offering, or IPO, whereby we sold a total of 4,800,000 shares of common stock at $16.00 pershare, resulting in net proceeds of $69.3 million after underwriting discounts, commissions, and offering expenses.6CIDARA THERAPEUTICS, INC. During the second half of 2015, we initiated and completed our Phase 1 clinical trials for CD101 IV. We conducted single ascending dose andmultiple ascending dose clinical trials in healthy volunteers, the results of which demonstrated that CD101 IV was well tolerated in all dose cohortsand exhibited a pharmacokinetic profile consistent with preclinical data and supportive of once-weekly dosing.Overview of Systemic Fungal Infections and the Antifungal MarketFungal infections pose significant medical challenges in both hospital and outpatient settings. While fungi are ubiquitous in our environment, theyare usually harmless for people with a normal immune system. Most fungal infections are topical and local in nature, occurring on the skin, in thevaginal tract, or in other parts of the body. However, if fungi access and proliferate in the bloodstream, these infections become systemic andpotentially life-threatening. Systemic fungal infections typically afflict patients whose immune systems have been compromised, such as patientsundergoing organ or bone marrow transplantation, chemotherapy or patients with AIDS.We estimate that the annual worldwide sales of prescription systemic antifungals are approximately $3.7 billion. This includes therapies used asprophylaxis (preventive) in the inpatient and outpatient setting, therapies used for the treatment of hospitalized patients, and therapies used for thetreatment of patients who are being discharged from the hospital. The figure below shows management’s estimates of days of therapy in thesevarious settings, in the United States.U.S. Days of Therapy (in millions) of Antifungals in Prophylaxis, Hospital and Outpatient (Discharge) Settings (2013) 7CIDARA THERAPEUTICS, INC. The majority of hospital infections are caused by two fungi, Candida and Aspergillus. These fungi are responsible for over 90% of theapproximately 97,000 annual deaths in the United States that we estimate are associated with fungal infections.U.S. Deaths in Patients with Hospital Treated Fungal Infections Physicians’ options for the treatment of fungal infections are limited by a lack of innovative therapies.Several factors have contributed to the low rate of antifungal and antibiotic drug development, including a previously challenging regulatoryenvironment that necessitated large and costly clinical trials. As a result, the number of anti-infectives in development has decreased, while anti-microbial resistance has increased due to overuse of existing agents.Systemic Candida Infections: A Growing Medical ChallengeSystemic Candida infections include candidemia and related cases of invasive candidiasis. In the United States, candidemia is the most commoncause of hospital-acquired bloodstream infections. While the limited data available on hospitalized patients varies widely, rates of between one andtwo cases per 1,000 hospital admissions have been reported in the United States, Europe and Latin America.Despite advances achieved in the diagnosis and treatment of candidemia, these infections continue to cause high mortality rates. According to astudy published in Clinical Infectious Disease (2009), candidemia has a mortality rate of 35% within 12 weeks of diagnosis. By contrast, the CDCreports that the mortality rate due to MRSA infections is 12.8%. Further, it is estimated that each case of candidemia results in an additional 23days of hospitalization and over $68,000 in treatment costs.Candida infections are particularly challenging to treat in patients whose immune systems have been compromised, such as patients undergoingorgan or bone marrow transplantation or chemotherapy, as well as those with weakened immune systems due to aging and other underlyingconditions, including, but not limited to, diabetes, metabolic diseases, HIV and chronic use of antibiotics.Current Therapeutic OptionsSystemic fungal infections are primarily treated using three classes of antifungals that target either fungal cell membranes or cell wall synthesis.However, each of these antifungal classes has limitations that we believe may be addressed by novel antifungals: ·Polyenes. Polyenes, first marketed in 1954, were the first drug class discovered to be effective against systemic fungal infections.Polyenes such as amphotericin B bind to and disrupt the integrity of ergosterol, an essential component of the fungal cell membrane.Polyenes are associated with severe and potentially life-threatening toxicities, including acute kidney and heart injury, since they are notselective to fungi and also bind to sterols in human tissues. In addition to the severe toxicity associated8CIDARA THERAPEUTICS, INC. with amphotericin B, many patients report problems with tolerability of this drug; 40% experience nausea and/or vomiting and up to 75%experience chills. Polyenes are typically administered by daily IV infusion. ·Azoles. Azoles were the next major drug class found to be effective in treating candidemia and related infections, and were firstmarketed in the 1980s. Azoles block the enzymatic pathway that produces ergosterol in the fungal cell membrane, thereby reducing thegrowth of the fungus but not killing it. This activity is referred to as fungistatic. Azoles are the most frequently used drugs for treatmentof systemic fungal infections. While these drugs are largely effective, their side effect profile includes an increased risk of serious livertoxicity as well as rash, visual disturbances, hallucinations and fetal cardiac abnormalities. Azoles are also known to cause druginteractions, including interactions with oral contraceptives, that can limit their utility. In addition, their widespread use has led to thedevelopment of resistance, which we believe may limit the future utility of the class. A number of azoles are available in IV, oral, andtopical formulations. They are typically administered on a daily basis. ·Echinocandins. Echinocandins, introduced in 2001, inhibit glucan synthase, a fungal specific enzyme required for synthesis of a keycomponent of fungal cell walls. Inhibition of this enzyme kills Candida. Echinocandins are increasingly recommended for the treatmentof fungal infections in the United States. The approved echinocandins, caspofungin, micafungin, and anidulafungin, are considered bothwell tolerated and safe relative to other antifungal drug classes. However, they must be administered daily by IV infusion, potentiallyextending the hospitalization of patients for the duration of therapy and thereby limiting their use mainly to inpatients.Despite the widespread continued use of each class of antifungals, we believe that market opportunities exist for novel therapeutics whichcombine the spectrum and safety of the echinocandins with a more convenient dosing schedule enabled by improved pharmacokineticcharacteristics.Emerging Resistance to AntifungalsThe CDC reports that certain species of Candida are becoming increasingly resistant to available antifungals, such as the azoles and approvedechinocandins. Widespread usage of antifungals in the azole class, in particular, has stimulated an increase in resistance. Non-albicans Candida,which have a higher rate of azole resistance, now cause approximately two-thirds of candidemia cases in the US.Our Solution—CD101 IV for the Treatment of CandidemiaOur lead product candidate, CD101 IV, has a prolonged half-life which, in contrast to all other echinocandins, may allow it to be developed as aonce-weekly IV therapy for the treatment and prevention of systemic fungal infections. We are developing CD101 IV to overcome the limitations ofthe echinocandin class and other antifungals by offering the following key benefits. ·Potential to treat resistant pathogens. We believe that CD101 IV can be used to treat fungal infections caused by drug-resistant fungi,including those currently resistant to echinocandins, due to its higher drug exposure early in the course of therapy. We expect that thishigher exposure early in the course of disease will improve outcomes in infections caused by both resistant as well as non-resistantpathogens. ·Single-agent treatment. Rather than treating patients with an IV echinocandin followed by an oral azole solely to enable earlier hospitaldischarge, CD101 IV would enable extended single-agent, echinocandin treatment for the full course of therapy, thereby enablingtreatment that is consistent with current guidance in the United States and European Union. ·Shorter and less costly hospital stays, and less costly outpatient costs. Physicians with access to a once-weekly echinocandin canpotentially discharge appropriate patients earlier and thereby reduce hospital costs, which account for over 70% of the overall treatmentcost of candidemia. Furthermore, early discharge from the hospital setting may reduce the risk for contracting nosocomialpathogens. For patients discharged on an echinocandin, once-weekly CD101 IV could eliminate significant outpatient infusion costs foronce-daily IV echinocandin therapy. 9CIDARA THERAPEUTICS, INC. ·Improved compliance. A once-weekly treatment of CD101 IV could facilitate compliance by eliminating the need for patients to returnto a hospital or outpatient center for a daily dose of an IV echinocandin, and could eliminate the likelihood of patient non-compliance forthose receiving oral step down therapy with a daily azole. ·Enabling or improving prophylaxis regimens. Some patients cannot receive azole prophylactic therapy due to drug interactions orpoor tolerability. We expect that once weekly CD101 IV therapy would provide for better prophylactic therapy on an inpatient andoutpatient basis, particularly for these patients.Preclinical StudiesIn Vitro Microbiology DataIn in vitro assays on a panel of 1,077 clinical isolates of Candida and Aspergillus strains, the activity of CD101 compared favorably with that of theapproved echinocandins, anidulafungin and caspofungin.Potency of CD101 Compared to Other Echinocandins The numbers in the table refer to the MIC90, or minimum concentration required to inhibit the growth of 90% of isolates. Lower values indicate thatthe antifungal agent is more potent as it is active at a lower concentration.In Vivo Efficacy DataWe studied CD101 IV and anidulafungin in a mouse model of disseminated candidiasis in immunosuppressed mice. CD101 IV and anidulafunginwere administered two hours after inoculation with Candida and the fungal burden in the kidneys, as measured by colony forming units, or CFUs,was determined after 24 hours. The results showed that CD101 IV was significantly more effective in reducing fungal burden compared toanidulafungin administered at 0.5 and 1.5 mg/kg doses. At 4.5 mg/kg, the efficacy of both drugs could not be differentiated since the fungal burdenwas at the lower level of detection. In the chart below, p<0.005 and p<0.05 mean that there is a greater than 99.5% and 95% probability,respectively, that the differences observed between treatments are not due to chance alone. Standard practice is to consider a p-value of 0.05 orless to be a statistically significant result.10CIDARA THERAPEUTICS, INC. Efficacy of CD101 IV and Anidulafungin in a Mouse Candidiasis Model Activity Against Resistant StrainsWe believe that CD101 IV can address important unmet medical needs in patients with candidemia caused by both susceptible and azole- orechinocandin-resistant Candida, as well as in patients at risk of invasive fungal infections who cannot take azole or polyene antifungals because ofdrug interactions or safety concerns. In a recent study of cancer patients with Candida infections from MD Anderson Cancer Center, patientprognosis was inversely correlated with resistance to caspofungin. Patients infected with the most drug-sensitive strains had a 28-day survival rateof 75% compared to only 25% for those with caspofungin-resistant strains. CD101 was tested against 23 echinocandin-non-susceptible Candidaisolates and demonstrated equivalent or greater potency against these strains compared to caspofungin, with up to eight-fold greater potency forseveral isolates. We believe that the high potency of CD101 against resistant strains, combined with the very high drug exposure associated withthe once-weekly dosing regimen, will result in improved efficacy in treating drug-resistant Candida infections.In order to be effective, an echinocandin drug should be present at as high an exposure early in therapy as is safely possible. The keypharmacokinetic parameters affecting exposure include the drug’s half-life, the Cmax, or the maximum concentration reached, and the overall drugexposure per dose, referred to as the AUC, or area under the curve. The maximum dose that can be used is based on the drug’s overall safetyprofile. With echinocandin drugs, high drug exposures early in therapy, as measured by Cmax or AUC, maximize the antifungal therapeutic benefitof these drugs. When a fungus starts to develop resistance to a drug, the MIC rises, which means that a higher drug exposure will be required inorder for the drug to have the same efficacy as it has against sensitive strains. Having a Cmax and an AUC that are far greater than the startingMIC provides the best chance of treating infections caused by strains resistant to other antifungals, including other echinocandins.CD101 IV Clinical Results Clinical Studies In November 2015, we obtained data from our single ascending dose (SAD) study. This was a Phase 1, randomized, double-blind, placebo-controlled, dose-escalation study to determine the safety, tolerability, and pharmacokinetics of single intravenous doses of CD101 in healthysubjects. Results demonstrated that CD101 IV11CIDARA THERAPEUTICS, INC. was well tolerated in all dose cohorts after single doses of 50 mg, 100 mg, 200 mg, and 400 mg. CD101 IV exhibited a pharmacokinetic profileconsistent with preclinical data and supportive of once-weekly dosing. In January 2016, we obtained data from our multiple ascending dose (MAD) Phase 1 study. This was a Phase 1, randomized, double-blind,placebo-controlled, dose-escalation study to determine the safety, tolerability, and pharmacokinetics of multiple intravenous doses of CD101 inhealthy subjects. Results demonstrated that CD101 IV was well tolerated in all dose cohorts after multiple doses of 100 mg, 200 mg, and 400 mg.CD101 IV exhibited a pharmacokinetic profile consistent with preclinical data and supportive of once-weekly dosing. For both Phase 1 studies, there were no serious adverse events (SAEs), severe Treatment Emergent Adverse Events (TEAEs), or relationshipsfor overall TEAEs. The majority of TEAEs were mild, and all TEAEs completely resolved by the end of the study. There were no drug-relatedTEAEs resulting from clinically significant hematology or clinical chemistry laboratory abnormalities at any dose. In addition, there were no safetyissues related to electrocardiograms, vital signs, or physical exam findings. Based on clinical results to date, we expect a single dose of CD101 IV to provide sufficient drug exposure for a period of seven days. In contrast,a single dose of anidulafungin provides sufficient drug exposure for only one day. The graph below presents the pharmacokinetic results from oursingle ascending dose Phase 1 clinical trial. Pharmacokinetic Properties of CD101 IV Based on results from our single ascending dose trial, CD101 IV has a prolonged half-life of greater than 80 hours in humans. CD101 IV may besafely developed as a once-weekly IV therapy, allowing patients with candidemia to receive sufficient drug exposure in just two to three doses tocover fourteen days of treatment following clearance of the active infection, which is the current recommended course of treatment.CD101 IV demonstrated a Cmax and an AUC significantly higher than other approved echinocandins. Based on the higher drug exposuredemonstrated by CD101 IV early in the course of therapy, we believe that CD101 IV can be12CIDARA THERAPEUTICS, INC. used to treat some fungal infections caused by drug-resistant fungi, including those currently resistant to echinocandins. We expect that thishigher exposure early in the course of disease will improve outcomes in infections caused by both resistant as well as non-resistant pathogens.Half-life of CD101 IV and Other Echinocandins in Humans PK measurements marked with an asterisk are from assays conducted by us. Other values are from studies published by third parties.Clinical Development PlanBased on discussions with the FDA, we assessed the pharmacokinetics and safety of CD101 IV in single and multiple ascending dose Phase 1clinical trials in healthy subjects. Results from these clinical trials have been used to select the dose for a Phase 2 clinical trial in candidemia,which we plan to initiate in the first half of 2016. This Phase 2 clinical trial will include approximately 90 patients with Candida bloodstreaminfection. The clinical trial will be double-blind, randomized and will include an echinocandin comparator group. We expect results from this trial inthe second half of 2017.In December 2014, we held a pre-IND meeting with the FDA during which agreement was reached that a single randomized, double-blind,comparative Phase 3 pivotal clinical trial, supported by the data from the Phase 1 and Phase 2 clinical trials, could suffice for approval of CD101IV for the indication of candidemia. A total safety database of at least 300 patients will be required, and possibly more if safety concerns are notedin the course of development. We plan to perform additional clinical research with CD101 IV in both invasive candidiasis and prophylaxis inpatients with high unmet need.Overview of the Vulvovaginal Candidiasis (VVC) and Antifungal Treatments for VVCThree quarters of all women have an episode of VVC at some point in their lives. Recurrent vulvovaginal candidiasis, or RVVC, is a condition inwhich three or more VVC infections occur within a year. RVVC is a painful chronic infection affecting four to five million women in the UnitedStates each year with 2.3 million patients seeking treatment from a physician for VVC.There are no therapies currently approved for the treatment of RVVC. Current off-label treatments include chronic self-medication with over-the-counter topical antifungals and the use of prescription fluconazole, an oral azole. Azoles are fungistatic, which means that they slow the growth of,but do not kill, the fungus. In addition, azoles are not active against certain species of Candida that cause VVC. Therefore, azoles often fail toprevent recurrent infections in women with RVVC and, even after prolonged treatments by azoles, VVC recurs in over 50% of patients. Bycontrast, echinocandins, including CD101, are fungicidal, which means that they kill the fungus, including the species of Candida that cause VVC.Antifungal agents in other classes such as the polyenes or echinocandins must be administered intravenously, usually in a hospital setting, andthus are not used for the treatment of VVC or RVVC.Our Solution—CD101 Topical for the Treatment of VVC and RVVCWe are developing CD101 topical, a topical formulation of CD101, for the treatment of VVC and RVVC. The active ingredient in CD101 topical isCD101, which has demonstrated potent fungicidal activity against Candida species in preclinical studies. Unlike currently available echinocandins,CD101 can be formulated topically due to its high solubility, stability and activity over a wide range of pH values, as demonstrated by testing todate. By contrast, anidulafungin, a currently marketed echinocandin, is virtually insoluble in water. We believe that the13CIDARA THERAPEUTICS, INC. fungicidal activity of CD101 at the site of infection has the potential to be more effective than the fungistatic azoles in reducing recurrence ofCandida infections in women with RVVC.Preclinical StudiesWe conducted preclinical efficacy studies across a range of gel and ointment formulations of CD101 topical and the studies demonstrate thatCD101 topical formulations can eliminate Candida in VVC animal models and demonstrates a clear dose-response relationship. We have alsoconducted preclinical studies to evaluate the tolerability, toxicity and pharmacokinetic profile of CD101 topical gel and ointment formulations whenadministered topically to female rats and monkeys. CD101 topical gel and ointment formulations of 1% and 10% CD101 were tested. No signs orsymptoms of toxicity were observed.Results showed that CD101 gel/ointment formulations, were highly effective at reducing fungal burden in the rat VVC model. The efficacy of the3% CD101 exceeded that of 2% miconazole and was comparable to 6.5% tioconazole. Therefore, CD101 may offer a promising alternative for thetreatment of VVC in humans. Activity of CD101 Gel or Ointment 3% Formulations (QDx3) and Comparators (Miconazole 2% and Tioconazole 6.5%) Against Candidaalbicans ATCC 44858ATCC = American Type Culture Collection; CFU = colony-forming units; LOD = limit of detection; QD = once daily.* ≥2-log decrease in mean CFU relative to corresponding untreated control† Statistically significant (p<0.05) decrease in mean CFU relative to untreated controlNote: percentages refer to animals that cleared the infectionSource: NC-091 Clinical Development PlanWe are planning to initiate a Phase 2 multi-site clinical trial in mid-2016 to investigate the safety, tolerability, and initial efficacy of CD101 topical inwomen with VVC. In this clinical study, two formulations with distinctly different release profiles will be tested: a fast-release 3% gel and a slow-release 6% ointment. Approximately 125 patients will be enrolled in this study, with 50 patients receiving the 3% gel, 50 patients receiving the 6%ointment, and 25 patients receiving oral fluconazole. Results from this clinical trial will be used to select the optimal formulation of CD101topical. Following the Phase 2 clinical trial, we plan to conduct two superiority Phase 3 clinical trials to assess the safety and efficacy versus oralfluconazole in acute and recurrent VVC. 14CIDARA THERAPEUTICS, INC. Our Proprietary Cloudbreak Immunotherapy PlatformWe believe that our Cloudbreak immunotherapy platform is a fundamentally new approach for the treatment of infectious disease. The design ofthe Cloudbreak immunotherapy platform recognizes that most infectious disease is due to a temporary deficiency in the function of the immunesystem. Our Cloudbreak development candidates are designed to address this deficiency by recruiting components of the patient’s immunesystem to the site of infection, enabling more effective treatment. Similar to the way that immunotherapy has the potential to revolutionize thetreatment of cancer by directing the immune system to destroy cancer cells, we believe that the Cloudbreak immunotherapy platform has thepotential to transform the treatment of infectious disease caused by a variety of fungal, bacterial and viral pathogens. The initial developmentcandidates emerging from the Cloudbreak immunotherapy platform are being developed for the treatment of invasive aspergillosis, a fungalinfection that results in a high rate of mortality. In addition to fungal infections, we plan to pursue applications for the treatment of bacterial andviral infections. In each application, we intend to apply our Cloudbreak immunotherapy platform to infections in at-risk patients who could benefitfrom an improved immune response. We plan to select a lead Cloudbreak development candidate in 2016.We are currently pursuing both small and large molecule approaches for Cloudbreak. Small molecule Cloudbreak candidates consist of twomolecules that are joined by a chemical linker: a targeting moiety, or TM, that recognizes a cell surface target and an effector moiety, or EM, thatis recognized by the immune system. In many cases, we can use a commercially approved drug as the TM. By contrast, large moleculeCloudbreak candidates leverage classical targeting and immune engaging components of antibodies and antibody fragments. Large moleculeCloudbreak candidates consist of a TM, which is an antibody that binds cell-surface antigen, and an EM that is recognized by the immunesystem. The coupling of the TM to the EM results in a bispecific molecule that can direct the immune system specifically to the targetedpathogen. Our Cloudbreak development candidates have the potential to feature the following attributes: ·Small or large molecule components with well-defined targets and efficient testing; ·selective binding to pathogens to amplify their immunogenicity (recognition by the immune system) and thereby efficiently recruit theinnate and adaptive immune system to assist in the rapid eradication of the pathogen; ·use as adjunctive therapy along with standard of care regimens; and ·broad applicability in the treatment of infectious diseases.The Cloudbreak immunotherapy platform is similar to certain cancer immunotherapies in that it uses molecules with two binding sites, one thatbinds to a cell surface target and a second that binds to specific receptors on immune cells. The modular composition of Cloudbreak compoundsallows for rapid exploration of combinations of targeting moiety (TM), effector moiety (EM), and linker domains, potentially enabling efficientdiscovery of anti-infective molecules with the desired potency, specificity and physical properties. 15CIDARA THERAPEUTICS, INC. ManufacturingWe do not own or operate, and currently have no plans to establish, any manufacturing facilities. We currently rely, and expect to continue to rely,on third parties to manufacture supplies of CD101 IV, CD101 topical, our Cloudbreak development candidates, and any future product candidates.CD101 is a semi-synthetic natural product. Thus, the manufacturing process for CD101 involves fermentation and synthetic chemical steps. Theprocess begins with fermentation to produce a natural product, which is conducted by third-party vendors. The natural product is then converted toCD101 in a series of chemical steps.Our third-party contract manufacturers are currently producing, and will produce in the future, our product and development candidates for use inour preclinical studies and clinical trials utilizing reliable and reproducible synthetic processes and common manufacturing techniques. We obtainour supplies from manufacturers on a purchase order basis and do not have any long-term arrangements. In addition, we do not currently havearrangements in place for bulk drug substance or drug product services. We intend to identify and qualify additional manufacturers to provide bulkdrug substance and drug product services prior to submission of an NDA to the FDA if necessary to ensure sufficient commercial quantities ofeach product.Intellectual PropertyThe proprietary nature of, and protection for, CD101 IV, CD101 topical, our Cloudbreak immunotherapy platform, our processes and our know-howare important to our business. We seek to protect our proprietary position through patent protection in the United States and internationally forCD101 IV, CD101 topical, our Cloudbreak immunotherapy platform and any other technology to which we have rights where available and whenappropriate. Our policy is to pursue, obtain, maintain and defend patent rights, developed internally and potentially licensed from third parties andto protect the technology, inventions and improvements that are commercially important to the development of our business. We also rely on tradesecrets that may be important to the development of our business. We cannot be sure that patents will be granted with respect to any of ourpending patent applications or with respect to any patent applications filed by us in the future, nor can we be sure that any of our existing patentsor any patents that may be granted to us in the future will be commercially useful in protecting our inventions, improvements and technology. Forthis and more comprehensive risks related to our intellectual property, please see “Risk Factors—Risks Related to Our Intellectual Property.”16CIDARA THERAPEUTICS, INC. Our success will depend significantly on our ability to: ·obtain and maintain patent and other proprietary protection for the technology, inventions and improvements we consider important toour business; ·defend and enforce our current and potential future patents; ·preserve the confidentiality of any of our trade secrets; and ·operate our business without infringing the patents and proprietary rights of third parties.We have established and continue to build proprietary positions for CD101 IV, CD101 topical and our product candidates and technology in theUnited States and abroad. As of February 29, 2016, our patent portfolio included six families of patent applications related to various aspects ofCD101, including CD101 IV and CD101 topical, and six families of patent applications related to our Cloudbreak immunotherapy platform.In May 2014, we entered into an asset purchase agreement with Seachaid Pharmaceuticals, Inc., or Seachaid, whereby we purchased intellectualproperty related to CD101. We issued 703,092 shares of common stock to Seachaid as consideration for the assets acquired.We own the rights to a first patent family that provides basic composition of matter coverage for CD101. This first patent family includes twogranted United States utility patents and one pending United States utility application, as well as foreign national or regional counterpart patentapplications pending in Canada, China, Europe, Hong Kong, India and Japan. We also own the rights to a second patent family directed to oralformulations and dosing regimens for CD101. This second patent family includes one pending U.S. utility patent application and foreign national orregional counterpart patent applications pending in Australia, Brazil, Canada, China, Europe, India, Israel, Japan, South Korea, Mexico and Russia.For any issued patents in these two families, we expect that they would expire in 2032 and 2033, respectively, excluding any additional term forpatent term adjustments or applicable patent term extensions.For our Cloudbreak immunotherapy platform, we own one pending Patent Cooperation Treaty application and five U.S. provisional patentapplications. If issued, patents from these patent applications could result in claims to both therapeutic compositions and methods of treatment.Any such patents would be expected to expire between 2034 and 2036, excluding any additional term for patent term adjustments or applicablepatent term extensions. Market exclusivity is the exclusive marketing right granted by the FDA and certain foreign equivalents upon the approval of a drug if certainstatutory requirements are met. When granted, the applicable regulatory authority will not approve another application to market the same drug forthe same indication during the period of market exclusivity. The length of market exclusivity depends on the type of exclusivity granted. Weintend to seek market exclusivity on our candidate products where appropriate. We have received orphan drug designation from the FDA for CD101 IV for the treatment of candidemia and invasive candidiasis. An orphan drugdesignation by the FDA makes CD101 IV eligible for seven years of market exclusivity for CD101 IV in candidemia and invasive candidiasis.In addition to the orphan drug designation, CD101 IV was designated as a Qualified Infectious Disease Product under the GAIN Act making iteligible for an additional five years of market exclusivity.Further, we seek trademark protection in the United States and internationally where available and when appropriate. We have filed for trademarkprotection in several countries for the Cidara trademark, which we use in connection with our pharmaceutical research and development services.We currently have registered trademarks for the Cidara mark in the United States, the European Union, and Australia and pending trademarkapplications in the United States and Australia. We also currently have a pending trademark application for Cloudbreak in the United States.CompetitionThe biopharmaceutical industry is characterized by intense and dynamic competition to develop new technologies and proprietary therapies. Anyproduct candidates that we successfully develop and commercialize will have to compete with existing therapies and new therapies that maybecome available in the future. We believe that17CIDARA THERAPEUTICS, INC. CD101 IV and CD101 topical and our Cloudbreak development candidates, paralleled with our scientific and development expertise in the field ofanti-infectives, provide us with competitive advantages over our peers. However, we face potential competition from various sources, includinglarger and better-funded pharmaceutical, specialty pharmaceutical, and biotechnology companies, as well as from generic drug manufacturers,academic institutions, governmental agencies and public and private research institutions.CD101 IV will primarily compete with antifungal classes for the treatment of candidemia, which include polyenes, azoles and echinocandins. Theapproved branded therapies for this indication include Cancidas (caspofungin, marketed by Merck & Co.), Eraxis (anidulafungin, marketed byPfizer, Inc.) and Mycamine (micafungin, marketed by Astellas Pharma US, Inc.). In addition, there are other generic products approved forcandidemia, marketed by companies such as Baxter Healthcare Corporation, Mylan Inc. and Glenmark Generics Inc., among others. In addition toapproved therapies, we expect that CD101 IV will compete with product candidates that we are aware of in clinical development by third parties,including SCY-078 (being developed by Scynexis, Inc.) and isavuconazole (being developed for the treatment of candidemia jointly by AstellasPharma and Basilea Pharmaceutica Ltd.).CD101 topical will primarily compete against azole agents (oral, topical and intravaginal), currently used in the treatment of VVC, as well as over-the-counter topical agents used to treat these conditions. The approved prescription therapies for VVC are Diflucan (fluconazole) and Terazol(terconazole). While there are several over-the-counter topical agents such as Monistat (miconazole), Gyne-Lotrimin (clotrimazole) or Gynazole-1(butoconazole) also used to treat VVC, we do not consider these products to be significant competitors due to their limited efficacy in RVVC andsevere acute VVC. Topical therapies for VVC are well accepted. Almost all of the OTC market is comprised of topical therapies, while theprescription market is 40% topical and 60% oral. In addition to approved therapies, we expect that CD101 topical will compete with productcandidates that we are aware of in clinical development by third parties, including VT-1161 (being developed by Viamet Pharmaceuticals, Inc.) andSCY-078 (being developed by Scynexis, Inc.), and albaconazole (being developed by Actavis plc).Many of our competitors, either alone or with their strategic partners, have substantially greater financial, technical and human resources than wedo and significantly greater experience in the discovery and development of product candidates, obtaining FDA and other regulatory approvals oftreatments and commercializing those treatments. These same competitors may invent technology that competes with our Cloudbreakimmunotherapy platform.Mergers and acquisitions in the biotechnology and pharmaceutical industries may result in even more resources being concentrated among asmaller number of our competitors. These competitors also compete with us in recruiting and retaining qualified scientific and managementpersonnel and establishing clinical study sites and subject registration for clinical studies, as well as in acquiring technologies complementary to,or necessary for, our programs. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborativearrangements with large and established companies.We expect any treatments that we develop and commercialize to compete on the basis of, among other things, efficacy, safety, convenience ofadministration and delivery, price, the level of generic competition and the availability of reimbursement from government and other third-partypayers.Our commercial opportunity could be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective,have fewer or less severe side effects, are more convenient or are less expensive than any products that we may develop. Our competitors alsomay obtain FDA or other regulatory approval for their products more rapidly than we may obtain approval for ours, which could result in ourcompetitors establishing a strong market position before we are able to enter the market. In addition, we expect that our therapeutic products, ifapproved, will be priced at a significant premium over competitive generic products and our ability to compete may be affected in many cases byinsurers or other third-party payers seeking to encourage the use of generic products.Government RegulationGovernment authorities in the United States, at the federal, state and local level, and in other countries extensively regulate, among other things,the research, development, testing, manufacture, including any manufacturing changes, packaging, storage, recordkeeping, labeling, advertising,promotion, distribution,18CIDARA THERAPEUTICS, INC. marketing, post-approval monitoring and reporting, import and export of pharmaceutical products, such as those we are developing.United States Drug Approval ProcessIn the United States, the FDA regulates drugs under the Federal Food, Drug, and Cosmetic Act, or FDCA, and implementing regulations. Theprocess of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state, local and foreign statutes and regulationsrequires the expenditure of substantial time and financial resources. Failure to comply with the applicable United States requirements at any timeduring the product development process, approval process or after approval may subject an applicant to a variety of administrative or judicialsanctions, such as the FDA’s refusal to approve pending applications, withdrawal of an approval, imposition of a clinical hold, issuance of warningletters and untitled letters, product recalls, product seizures, total or partial suspension of production or distribution injunctions, fines, refusals ofgovernment contracts, restitution, disgorgement of profits or civil or criminal penalties.The process required by the FDA before a drug may be marketed in the United States generally involves the following: ·contract manufacturing expenses, primarily for the production of clinical supplies; ·completion of preclinical laboratory tests, animal studies and formulation studies in compliance with the FDA’s good laboratory practice,or GLP, regulations; ·submission to the FDA of an investigational new drug, or IND, which must become effective before human clinical trials may begin; ·approval by an independent institutional review board, or IRB, at each clinical site before each trial may be initiated; ·performance of adequate and well-controlled human clinical trials in accordance with good clinical practices, or GCP, to establish thesafety and efficacy of the proposed drug for each indication; ·submission to the FDA of a new drug application, or NDA; ·satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the product is produced to assesscompliance with current good manufacturing practices, or cGMP, requirements and to assure that the facilities, methods and controlsare adequate to preserve the drug’s identity, strength, quality and purity; and ·FDA review and approval of the NDA.Preclinical Studies and INDPreclinical studies include laboratory evaluation of product chemistry and formulation, as well as in vitro and animal studies to assess the potentialfor adverse events, and in some cases, to establish a rationale for therapeutic use. The conduct of preclinical studies is subject to federalregulations and requirements, including GLP regulations for safety/toxicology studies. An IND sponsor must submit the results of the preclinicaltests, together with manufacturing information, analytical data, any available clinical data or literature and plans for clinical trials, among otherthings, to the FDA as part of an IND. Some long-term preclinical testing, such as animal tests of reproductive adverse events and carcinogenicity,may continue after the IND is submitted. An IND automatically becomes effective 30 days after receipt by the FDA, unless before that time, theFDA raises concerns or questions related to one or more proposed clinical trials and places the trial on clinical hold. In such a case, the INDsponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin. As a result, submission of an IND may not resultin the FDA allowing clinical trials to commence.Clinical TrialsClinical trials involve the administration of the investigational new drug to human subjects under the supervision of qualified investigators inaccordance with GCP requirements, which include, among other things, the requirement that all research subjects provide their informed consentin writing before their participation in any clinical trial. Clinical trials are conducted under written study protocols detailing, among other things, theobjectives of the study, the parameters to be used in monitoring safety and the effectiveness criteria to be evaluated. A protocol for19CIDARA THERAPEUTICS, INC. each clinical trial and any subsequent protocol amendments must be submitted to the FDA as part of the IND. In addition, an IRB at eachinstitution participating in the clinical trial must review and approve the plan for any clinical trial before it commences at that institution, and theIRB must conduct continuing review. The IRB must review and approve, among other things, the study protocol and informed consent informationto be provided to study subjects. An IRB must operate in compliance with FDA regulations.Information about certain clinical trials must be submitted within specific timeframes to the National Institutes of Health for public dissemination atwww.clinicaltrials.gov. Human clinical trials are typically conducted in three sequential phases, which may overlap or be combined: ·Phase 1: The drug is initially introduced into healthy human subjects or patients with the target disease or condition and tested forsafety, dosage tolerance, absorption, metabolism, distribution, excretion and, if possible, to gain an early indication of its effectiveness. ·Phase 2: The drug is administered to a limited patient population to identify possible adverse effects and safety risks, to preliminarilyevaluate the efficacy of the product for specific targeted diseases and to determine dosage tolerance and optimal dosage. ·Phase 3: The drug is administered to an expanded patient population in adequate and well-controlled clinical trials to generate sufficientdata to statistically confirm the efficacy and safety of the product for approval, to establish the overall risk-benefit profile of the productand to provide adequate information for the labeling of the product.Progress reports detailing the results of the clinical trials must be submitted at least annually to the FDA and, more frequently, if serious adverseevents occur. Phase 1, Phase 2 and Phase 3 clinical trials may not be completed successfully within any specified period, or at all. Furthermore,the FDA or the sponsor may suspend or terminate a clinical trial at any time on various grounds, including a finding that the research subjects arebeing exposed to an unacceptable health risk. Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution if the clinicaltrial is not being conducted in accordance with the IRB’s requirements or if the drug has been associated with unexpected serious harm topatients.Marketing ApprovalAssuming successful completion of the required clinical testing, the results of the preclinical studies and clinical trials, together with detailedinformation relating to the product’s chemistry, manufacture, controls and proposed labeling, among other things, are submitted to the FDA as partof an NDA requesting approval to market the product for one or more indications. Under federal law, the submission of most NDAs is additionallysubject to a substantial application user fee, and the sponsor of an approved NDA is also subject to annual product and establishment user fees,which fees are typically increased annually.The FDA conducts a preliminary review of all NDAs within the first 60 days after submission before accepting them for filing to determine whetherthey are sufficiently complete to permit substantive review. The FDA may request additional information rather than accept an NDA for filing. Inthis event, the application must be resubmitted with the additional information. The resubmitted application is also subject to review before theFDA accepts it for filing. Once the submission is accepted for filing, the FDA begins an in-depth substantive review. The FDA has agreed tospecified performance goals in the review of NDAs. Under these goals, the FDA has committed to review most such applications for non-priorityproducts within 10 months, and most applications for priority review products, that is, drugs that the FDA determines represent a significantimprovement over existing therapy, within six months from filing. The review process may be extended by the FDA for three additional months toconsider certain information or clarification regarding information already provided in the submission. The FDA may also refer applications for noveldrugs or products that present difficult questions of safety or efficacy to an advisory committee, typically a panel that includes clinicians and otherexperts, for review, evaluation and a recommendation as to whether the application should be approved. The FDA is not bound by therecommendations of an advisory committee, but it considers such recommendations carefully when making decisions.Before approving an NDA, the FDA typically will inspect the facility or facilities where the product is manufactured. The FDA will not approve anapplication unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and adequate toassure consistent production of the product within20CIDARA THERAPEUTICS, INC. required specifications. In addition, before approving an NDA, the FDA will typically inspect one or more clinical sites to assure compliance withGCP and integrity of the clinical data submitted.The testing and approval process requires substantial time, effort and financial resources, and each may take many years to complete. Dataobtained from clinical activities are not always conclusive and may be susceptible to varying interpretations, which could delay, limit or preventregulatory approval. The FDA may not grant approval on a timely basis, or at all. We may encounter difficulties or unanticipated costs in our effortsto develop our product candidates and secure necessary governmental approvals, which could delay or preclude us from marketing our products.After the FDA’s evaluation of the NDA and inspection of the manufacturing facilities, the FDA may issue an approval letter or a complete responseletter. An approval letter authorizes commercial marketing of the drug with specific prescribing information for specific indications. A completeresponse letter generally outlines the deficiencies in the submission and may require substantial additional testing or information in order for theFDA to reconsider the application. If and when those deficiencies have been addressed to the FDA’s satisfaction in a resubmission of the NDA,the FDA will issue an approval letter. The FDA has committed to reviewing such resubmissions in two or six months depending on the type ofinformation included. Even with submission of this additional information, the FDA ultimately may decide that the application does not satisfy theregulatory criteria for approval and refuse to approve the NDA. Even if the FDA approves a product, it may limit the approved indications for usefor the product, require that contraindications, warnings or precautions be included in the product labeling, require that post-approval studies,including Phase 4 clinical trials, be conducted to further assess a drug’s safety after approval, require testing and surveillance programs to monitorthe product after commercialization, or impose other conditions, including distribution restrictions or other risk management mechanisms, includingRisk Evaluation and Mitigation Strategies, or REMs, which can materially affect the potential market and profitability of the product. The FDA mayprevent or limit further marketing of a product based on the results of post-market studies or surveillance programs. After approval, some types ofchanges to the approved product, such as adding new indications, manufacturing changes and additional labeling claims, are subject to furthertesting requirements and FDA review and approval.Fast Track DesignationThe FDA is required to facilitate the development and expedite the review of drugs that are intended for the treatment of a serious or life-threatening condition for which there is no effective treatment and which demonstrate the potential to address unmet medical needs for thecondition. Under the fast track program, the sponsor of a new product candidate may request the FDA to designate the product for a specificindication as a fast track product concurrent with or after the submission of the IND for the product candidate. The FDA must determine if theproduct candidate qualifies for fast track designation within 60 days after receipt of the sponsor’s request.In addition to other benefits, such as the ability of the sponsor to use surrogate endpoints in the evaluation of the pivotal clinical trials and havemore frequent interactions with the FDA, the FDA may initiate review of sections of a fast track product’s NDA before the application is complete.This rolling review is available if the applicant provides and the FDA approves a schedule for the submission of the remaining information and theapplicant pays applicable user fees. However, the FDA’s time period goal for reviewing a fast track application does not begin until the last sectionof the NDA is submitted. In addition, the fast track designation may be withdrawn by the FDA if the FDA believes that the designation is no longersupported by data emerging in the clinical trial process.Priority ReviewUnder FDA policies, a product candidate may be eligible for priority review, or review generally within a six-month time frame from the time acomplete application is received. Products regulated by the FDA’s Center for Drug Evaluation and Research, or CDER, are eligible for priorityreview if they provide a significant improvement compared to marketed products in the treatment, diagnosis or prevention of a disease. A fasttrack designated product candidate would ordinarily meet the FDA’s criteria for priority review.21CIDARA THERAPEUTICS, INC. Accelerated ApprovalUnder the FDA’s accelerated approval regulations, the FDA may approve a drug for a serious or life-threatening illness that provides meaningfultherapeutic benefit to patients over existing treatments based upon a surrogate endpoint that is reasonably likely to predict clinical benefit. Inclinical trials, a surrogate endpoint is a measurement of laboratory or clinical signs of a disease or condition that substitutes for a directmeasurement of how a patient feels, functions or survives. Surrogate endpoints can often be measured more easily or more rapidly than clinicalendpoints. A product candidate approved on this basis is subject to rigorous post-marketing compliance requirements, including the completion ofPhase 4 or post-approval clinical trials to confirm the effect on the clinical endpoint. Failure to conduct required post-approval trials, or confirm aclinical benefit during post-marketing studies, would allow the FDA to withdraw the drug from the market on an expedited basis. All promotionalmaterials for product candidates approved under accelerated regulations are subject to prior review by the FDA.Breakthrough Therapy DesignationUnder the provisions of the Food and Drug Administration Safety and Innovation Act, or FDASIA, enacted in 2012, a sponsor can requestdesignation of a product candidate as a “breakthrough therapy.” A breakthrough therapy is defined as a drug that is intended, alone or incombination with one or more other drugs, to treat a serious or life-threatening disease or condition, and preliminary clinical evidence indicates thatthe product candidate may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such assubstantial treatment effects observed early in clinical development. Drugs designated as breakthrough therapies are also eligible for acceleratedapproval. The FDA must take certain actions, such as holding timely meetings and providing advice, intended to expedite the development andreview of an application for approval of a breakthrough therapy. Even if a product candidate qualifies for one or more of these programs, the FDAmay later decide that the product candidate no longer meets the conditions for qualification or decide that the time period for FDA review orapproval will not be shortened.Orphan DrugsUnder the Orphan Drug Act, the FDA may grant orphan drug designation to drugs intended to treat a rare disease or condition, which is generallydefined as a disease or condition that affects fewer than 200,000 individuals in the United States. Orphan drug designation must be requestedbefore submitting an NDA. After the FDA grants orphan drug designation, the generic identity of the drug and its potential orphan use are disclosedpublicly by the FDA. Orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review and approvalprocess. The first NDA applicant to receive FDA approval for a particular active ingredient to treat a particular disease with FDA orphan drugdesignation is entitled to a seven-year exclusive marketing period in the United States for that product, for that indication. During the seven-yearexclusivity period, the FDA may not approve any other applications to market the same drug for the same orphan indication, except in limitedcircumstances, such as a showing of clinical superiority to the product with orphan drug exclusivity in that it is shown to be safer, more effectiveor makes a major contribution to patient care. Orphan drug exclusivity does not prevent the FDA from approving a different drug for the samedisease or condition, or the same drug for a different disease or condition. Among the other benefits of orphan drug designation are tax credits forcertain research and a waiver of the NDA application user fee.Qualified Infectious Disease ProductsIn response to the growing unmet medical need in the area of serious bacterial infections, the Food and Drug Administration Safety and InnovationAct became law in July 2012 and included the Generating Antibiotic Incentives Now Act, or the GAIN Act. The GAIN Act is intended to provideincentives, including, for example, access to expedited FDA review for approval and five years of potential market exclusivity extension, for thedevelopment of new, qualified infectious disease products, or QIDP, including antibacterial or antifungal drugs intended to treat serious or life-threatening infections that are resistant to treatment, or that treat qualifying resistant pathogens identified by the FDA. A sponsor must requestQIDP designation for a new drug before an NDA is submitted and, if designated as a QIDP and approved, is eligible for an additional five years ofexclusivity beyond any period of exclusivity to which it would have otherwise been entitled. In addition, a QIDP receives NDA priority review andFast Track designation.22CIDARA THERAPEUTICS, INC. Pediatric Exclusivity and Pediatric UseUnder the Best Pharmaceuticals for Children Act, or the BPCA, certain drugs may obtain an additional six months of exclusivity, if the sponsorsubmits information requested in writing by the FDA (a Written Request) relating to the use of the active moiety of the drug in children. The FDAmay not issue a Written Request for studies on unapproved or approved indications or where it determines that information relating to the use of adrug in a pediatric population, or part of the pediatric population, may not produce health benefits in that population.In addition, the Pediatric Research Equity Act, or PREA, requires a sponsor to conduct pediatric studies for most drugs and biologics, for a newactive ingredient, new indication, new dosage form, new dosing regimen or new route of administration. Under PREA, original NDAs, biologicslicense applications and supplements thereto, must contain a pediatric assessment unless the sponsor has received a deferral or waiver. Unlessotherwise required by regulation, PREA does not apply to any drug for an indication for which an orphan drug designation has been granted. Therequired assessment must assess the safety and effectiveness of the product for the claimed indications in all relevant pediatric subpopulationsand support dosing and administration for each pediatric subpopulation for which the product is safe and effective. The sponsor or FDA mayrequest a deferral of pediatric studies for some or all of the pediatric subpopulations. A deferral may be granted for several reasons, including afinding that the drug or biologic is ready for approval for use in adults before pediatric studies are complete or that additional safety oreffectiveness data needs to be collected before the pediatric studies begin. After April 2013, the FDA must send a non-compliance letter to anysponsor that fails to submit the required assessment, keep a deferral current or fails to submit a request for approval of a pediatric formulation.Other Regulatory RequirementsAny drug manufactured or distributed by us pursuant to FDA approvals are subject to pervasive and continuing regulation by the FDA, including,among other things, requirements relating to recordkeeping, periodic reporting, product sampling and distribution, advertising and promotion andreporting of adverse experiences with the product. After approval, most changes to the approved product, such as adding new indications or otherlabeling claims are subject to prior FDA review and approval.The FDA may impose a number of post-approval requirements, including REMs, as a condition of approval of an NDA. For example, the FDA mayrequire post-marketing testing, including Phase 4 clinical trials, and surveillance to further assess and monitor the product’s safety andeffectiveness after commercialization.In addition, drug manufacturers and other entities involved in the manufacture and distribution of approved drugs are required to register theirestablishments with the FDA and state agencies, and are subject to periodic unannounced inspections by the FDA and these state agencies forcompliance with cGMP requirements. Changes to the manufacturing process are strictly regulated and often require prior FDA approval beforebeing implemented. FDA regulations also require investigation and correction of any deviations from cGMP and impose reporting anddocumentation requirements upon us and any third-party manufacturers that we may decide to use. Accordingly, manufacturers must continue toexpend time, money and effort in the areas of production and quality control to maintain cGMP compliance.Once an approval is granted, the FDA may withdraw the approval if compliance with regulatory requirements and standards is not maintained or ifproblems occur after the product reaches the market. Later discovery of previously unknown problems with a product, including adverse events ofunanticipated severity or frequency, or with manufacturing processes, or failure to comply with regulatory requirements, may result in revisions tothe approved labeling to add new safety information, imposition of post-market studies or clinical trials to assess new safety risks or imposition ofdistribution or other restrictions under a Risk Evaluation and Mitigation Strategy program. Other potential consequences include, among otherthings: ·restrictions on the marketing or manufacturing of the product, complete withdrawal of the product from the market or product recalls; ·fines, warning letters or holds on post-approval clinical trials; ·refusal of the FDA to approve pending applications or supplements to approved applications, or suspension or revocation of productlicense approvals;23CIDARA THERAPEUTICS, INC. ·product seizure or detention, or refusal to permit the import or export of products; or ·consent decrees, injunctions or the imposition of civil or criminal penalties.The FDA strictly regulates marketing, labeling, advertising and promotion of products that are placed on the market. Drugs may be promoted onlyfor the approved indications and in accordance with the provisions of the approved label. The FDA and other agencies actively enforce the lawsand regulations prohibiting the promotion of off label uses, and a company that is found to have improperly promoted off label uses may be subjectto significant liability.Additional ProvisionsIn addition to FDA restrictions on marketing of pharmaceutical products, several other types of state and federal laws restrict our businessactivities, including certain marketing practices. These laws include, without limitation, anti-kickback laws, false claims laws, data privacy andsecurity laws, as well as transparency laws regarding payments or other items of value provided to healthcare providers.The federal healthcare program anti-kickback statute prohibits, among other things, knowingly and willfully offering, paying, soliciting or receivingremuneration to induce or in return for purchasing, leasing, ordering or arranging for the purchase, lease or order of any healthcare item, good,facility or service reimbursable under Medicare, Medicaid or other federal healthcare programs. The term “remuneration” has been broadlyinterpreted to include anything of value. This statute has been interpreted to apply to arrangements between pharmaceutical manufacturers on theone hand and prescribers, purchasers and formulary managers on the other. Although there are a number of statutory exceptions and regulatorysafe harbors protecting certain common activities from prosecution or other regulatory sanctions, the exceptions and safe harbors are drawnnarrowly, and practices that involve remuneration that are alleged to be intended to induce prescribing, purchases or recommendations may besubject to scrutiny if they do not qualify for an exception or safe harbor. Failure to meet all of the requirements of a particular applicable statutoryexception or regulatory safe harbor does not make the conduct per se illegal under the federal healthcare program anti-kickback statute. Instead,the legality of the arrangement will be evaluated on a case-by-case basis based on a cumulative review of all its facts and circumstances. Severalcourts have interpreted the statute’s intent requirement to mean that if any one purpose of an arrangement involving remuneration is to inducereferrals of federal healthcare covered business, the federal healthcare program anti-kickback statute has been violated. Additionally, the intentstandard under the federal healthcare program anti-kickback statute was amended by the Patient Protection and Affordable Care Act of 2010, asamended by the Health Care and Education Reconciliation Act of 2010, collectively the Affordable Care Act, to a stricter standard such that aperson or entity no longer needs to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation. Inaddition, the Affordable Care Act codified case law that a claim including items or services resulting from a violation of the federal healthcareprogram anti-kickback statute constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act.Federal false claims laws, including the civil False Claims Act, and civil monetary penalties laws, prohibit any person or entity from, among otherthings, knowingly presenting, or causing to be presented, a false claim for payment to the federal government, or knowingly making, or causing tobe made, a false statement to have a false claim paid. Pharmaceutical and other healthcare companies have been prosecuted under these lawsfor, among other things, allegedly inflating drug prices they report to pricing services, which in turn were used by the government to set Medicareand Medicaid reimbursement rates, and for allegedly providing free product to customers with the expectation that the customers would bill federalprograms for the product. In addition, certain marketing practices, including off-label promotion, may also violate false claims laws.The federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, created additional federal criminal statutes that prohibit amongother actions, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, including privatethird-party payors, knowingly and willfully embezzling or stealing from a healthcare benefit program, willfully obstructing a criminal investigation ofa healthcare offense, and knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious orfraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services. Like the federal healthcare programanti-kickback statute, the Affordable Care Act amended the intent standard for certain healthcare fraud under HIPAA such that a person or entityno longer needs to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation.24CIDARA THERAPEUTICS, INC. In addition, we may be subject to data privacy and security regulation by both the federal government and the states in which we conduct ourbusiness. HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, and its implementingregulations, imposes certain requirements relating to the privacy, security and transmission of individually identifiable health information. Amongother things, HITECH makes HIPAA’s security standards directly applicable to business associates, independent contractors or agents of coveredentities that receive or obtain protected health information in connection with providing a service on behalf of a covered entity. HITECH alsocreated four new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates,and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA lawsand seek attorneys’ fees and costs associated with pursuing federal civil actions.Additionally, the federal Physician Payments Sunshine Act, created under the Affordable Care Act, and its implementing regulations, requirecertain manufacturers of drugs, devices, biologicals and medical supplies for which payment is available under Medicare, Medicaid or theChildren’s Health Insurance Program (with certain exceptions) to report annually information related to certain payments or other transfers of valueprovided to physicians and teaching hospitals, or to entities or individuals at the request of, or designated on behalf of, the physicians andteaching hospitals, and applicable manufacturers and group purchasing organizations to report annually certain ownership and investment interestsheld by physicians and their immediate family members.The majority of states also have statutes or regulations similar to the aforementioned federal fraud and abuse laws, some of which are broader inscope and apply to items and services reimbursed under Medicaid and other state programs, or, in several states, apply regardless of the payor.Further, some state laws require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and therelevant compliance guidance promulgated by the federal government in addition to requiring drug manufacturers to report information related topayments or other transfers of value provided to physicians and other health care providers and entities or marketing expenditures.If our operations are found to be in violation of any of the health regulatory laws described above or any other laws that apply to us, we may besubject to penalties, potentially significant criminal and civil and/or administrative penalties, damages, fines, disgorgement, imprisonment,exclusion from participation in government healthcare programs, as well as contractual damages, reputational harm, administrative burdens,diminished profits and future earnings, and the curtailment or restructuring of our operations, any of which could adversely affect our ability tooperate our business and our results of operations.Coverage and ReimbursementSales of pharmaceutical products depend in significant part on the availability of coverage and adequate reimbursement by third-party payors.Patients who are prescribed treatments for their conditions and providers performing the prescribed services generally rely on third-party payors toreimburse all or part of the associated healthcare costs. Patients and providers are unlikely to use our products unless coverage is provided andreimbursement is adequate to cover a significant portion of the cost of therapies in which our products are used. In the United States, no uniformpolicy of coverage and reimbursement for products exists among third-party payors. Therefore, coverage and reimbursement for products candiffer significantly from payor to payor. Decisions regarding the extent of coverage and amount of reimbursement to be provided for each of ourproduct candidates will be made on a plan by plan basis. One payor’s determination to provide coverage for a product does not assure that otherpayors will also provide coverage, and adequate reimbursement, for the product. Additionally, the coverage determination process is often a time-consuming and costly process that will require us to provide scientific and clinical support for the use of our product candidates to each payorseparately, with no assurance that coverage and adequate reimbursement will be obtained.Healthcare ReformCurrent and future legislative proposals to further reform healthcare or reduce healthcare costs may result in lower reimbursement for our products.The cost containment measures that payors and providers are instituting and the effect of any healthcare reform initiative implemented in thefuture could significantly reduce our revenues from the sale of our products.25CIDARA THERAPEUTICS, INC. For example, implementation of the Affordable Care Act has substantially changed healthcare financing and delivery by both governmental andprivate insurers, and significantly impacted the pharmaceutical industry. The Affordable Care Act, among other things, established an annual,nondeductible fee on any entity that manufactures or imports certain specified branded prescription drugs and biologic agents, revised themethodology by which rebates owed by manufacturers to the state and federal government for covered outpatient drugs under the Medicaid DrugRebate Program are calculated, increased the minimum Medicaid rebates owed by most manufacturers under the Medicaid Drug Rebate Program,extended the Medicaid Drug Rebate program to utilization of prescriptions of individuals enrolled in Medicaid managed care organizations, andprovided incentives to programs that increase the federal government’s comparative effectiveness research. Since its enactment there have beenjudicial and Congressional challenges to certain aspects of the Affordable Care Act, and we expect there will be additional challenges andamendments to it in the future.In addition, other legislative changes have been proposed and adopted since the Affordable Care Act was enacted. In August 2011, the Presidentsigned into law the Budget Control Act of 2011, which, among other things, created the Joint Select Committee on Deficit Reduction to recommendto Congress proposals in spending reductions. The Joint Select Committee did not achieve a targeted deficit reduction of at least $1.2 trillion forthe years 2013 through 2021, triggering the legislation’s automatic reduction to several government programs. This includes reductions to Medicarepayments to providers of 2% per fiscal year, which went into effect in April 2013 and, due to subsequent legislative amendments, will remain ineffect through 2025 unless additional congressional action is taken. Additionally, in January 2013, President Obama signed into law the AmericanTaxpayer Relief Act of 2012, which, among other things, reduced Medicare payments to several providers and increased the statute of limitationsperiod for the government to recover overpayments to providers from three to five years. More recently, there has been heightened governmentalscrutiny recently over the manner in which manufacturers set prices for their marketed products. For example, there have been several recentCongressional inquiries and proposed bills designed to, among other things, bring more transparency to drug pricing, review the relationshipbetween pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drug products.We expect that additional state and federal healthcare reform measures will be adopted in the future, any of which could limit the amounts thatfederal and state governments will pay for healthcare products and services, which could result in reduced demand for our products or additionalpricing pressure.Foreign RegulationIn order to market any product outside of the United States, we would need to comply with numerous and varying regulatory requirements of othercountries regarding safety and efficacy and governing, among other things, clinical trials, marketing authorization, commercial sales anddistribution of our products. Whether or not we obtain FDA approval for a product, we would need to obtain the necessary approvals by thecomparable regulatory authorities of foreign countries before we can commence clinical trials or marketing of the product in those countries. Theapproval process varies from country to country and can involve additional product testing and additional administrative review periods. The timerequired to obtain approval in other countries might differ from and be longer than that required to obtain FDA approval. Regulatory approval in onecountry does not ensure regulatory approval in another, but a failure or delay in obtaining regulatory approval in one country may negatively impactthe regulatory process in others.New Legislation and RegulationsFrom time to time, legislation is drafted, introduced and passed in Congress that could significantly change the statutory provisions governing thetesting, approval, manufacturing and marketing of products regulated by the FDA. In addition to new legislation, FDA regulations and policies areoften revised or interpreted by the agency in ways that may significantly affect our business and our products. It is impossible to predict whetherfurther legislative changes will be enacted or whether FDA regulations, guidance, policies or interpretations changed or what the effect of suchchanges, if any, may be.EmployeesAs of February 29, 2016, we had 48 employees, 20 of whom hold Ph.D. or M.D. degrees, 33 of whom were engaged in research and developmentactivities and 15 of whom were engaged in business development,26CIDARA THERAPEUTICS, INC. finance, information systems, facilities, human resources or administrative support. None of our employees is subject to a collective bargainingagreement. We consider our relationship with our employees to be good.FacilitiesWe lease a 29,638 square foot facility in San Diego, California for administrative and research and development activities. Our lease expires onDecember 31, 2018 and we have two individual two-year extension option rights. We believe that our existing facilities are adequate to meet ourcurrent needs, and that suitable additional alternative spaces will be available in the future on commercially reasonable terms.Corporate InformationWe were incorporated in Delaware as K2 Therapeutics, Inc. in December 2012. In July 2014, we changed our name to Cidara Therapeutics, Inc.Our principal executive offices are located at 6310 Nancy Ridge Drive, Suite 101, San Diego, California 92121, and our telephone number is(858) 752-6170. Our corporate website address is www.cidara.com. Information contained on or accessible through our website is not a part of thisprospectus, and the inclusion of our website address in this prospectus is an inactive textual reference only.We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act, or the JOBS Act. We will remain an emerginggrowth company until the earlier of (1) the last day of the fiscal year (a) following the fifth anniversary of the completion of our initial public offeringin April 2015, (b) in which we have total annual gross revenue of at least $1 billion or (c) in which we are deemed to be a large accelerated filer,which requires the market value of our common stock that is held by non-affiliates to exceed $700 million as of the prior June 30th, and (2) thedate on which we have issued more than $1 billion in non-convertible debt during the prior three-year period. References to “emerging growthcompany” in this Annual Report have the meaning associated with it in the JOBS Act.In March 2016, we formed a wholly owned subsidiary, Cidara Therapeutics UK Limited, in England for the purpose of developing our productcandidates in Europe.Legal ProceedingsFrom time to time, we may be involved in various claims and legal proceedings relating to claims arising out of our operations. We are notcurrently a party to any legal proceedings that, in the opinion of our management, are likely to have a material adverse effect on our business.Regardless of outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of managementresources and other factors. Item 1A. Risk Factors.You should carefully consider the following risk factors, as well as the other information in this report and in our public filings, before decidingwhether to purchase, hold or sell shares of our common stock. The occurrence of any of the following risks could harm our business, financialcondition, results of operations and/or growth prospects or cause our actual results to differ materially from those contained in forward-lookingstatements we have made in this report and those we may make from time to time.27CIDARA THERAPEUTICS, INC. Risks Related to Drug Discovery, Development and CommercializationWe are very early in our development efforts, which may not be successful.All of our product candidates other than CD101 IV are in the preclinical stage of development and we have only recently completed a Phase 1clinical trial of CD101 IV. Because of the early stage of our development efforts, we are still in the process of determining the clinical developmentpath for our current and future product candidates. As a result, the timing and costs of the regulatory paths we will follow and marketing approvalsremain uncertain. Our ability to generate product revenue, which we do not expect will occur for many years, if ever, will depend heavily on thesuccessful development and eventual commercialization of our early-stage product candidates. The success of CD101 IV, CD101 topical, and anyother product candidates we may develop will depend on many factors, including the following: ·successful completion of preclinical studies; ·successful enrollment in, and completion of, clinical trials; ·demonstrating safety and efficacy; ·receipt of marketing approvals from applicable regulatory authorities; ·establishing commercial manufacturing capabilities or making arrangements with third-party manufacturers; ·obtaining and maintaining patent and trade secret protection and non-patent exclusivity for our product candidates and technologies; ·launching commercial sales of the product candidates, if and when approved, whether alone or selectively in collaboration with others; ·acceptance of the product candidates, if and when approved, by patients, the medical community and third-party payors; ·effectively competing with other therapies; ·a continued acceptable safety profile of the products following approval; and ·enforcing and defending intellectual property rights and claims.If we do not accomplish one or more of these goals in a timely manner, or at all, we could experience significant delays or an inability tosuccessfully commercialize our product candidates, which would harm our business.If clinical trials of our product candidates fail to demonstrate safety and efficacy to the satisfaction of regulatory authorities or do nototherwise produce positive results, we may incur additional costs or experience delays in completing, or ultimately be unable tocomplete, the development and commercialization of our product candidates.Before obtaining marketing approval from regulatory authorities for the sale of our product candidates, we must complete preclinical developmentand then conduct extensive clinical trials to demonstrate the safety and efficacy of our product candidates in humans. Clinical testing isexpensive, difficult to design and implement, can take many years to complete and is uncertain as to outcome. A failure of one or more clinicaltrials could occur at any stage of testing. The outcome of preclinical testing and early clinical trials may not be predictive of the success of laterclinical trials, and interim results of a particular clinical trial do not necessarily predict final results of that trial. Moreover, preclinical and clinicaldata are often susceptible to multiple interpretations and analyses. Many companies that have believed their product candidates performedsatisfactorily in preclinical studies and clinical trials have nonetheless failed to obtain marketing approval of their products. For example, the highrate of correlation for clinical efficacy for antifungals and anti-infectives based on preclinical data may not apply for our current or future productcandidates, and any of the potential benefits that we anticipate for human clinical use may not be realized.28CIDARA THERAPEUTICS, INC. We may experience numerous unforeseen events during, or as a result of, clinical trials that could delay or prevent our ability to receive marketingapproval or commercialize our product candidates, including that: ·regulators or institutional review boards may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial ata prospective trial site; ·we may have delays in reaching or fail to reach agreement on acceptable clinical trial contracts or clinical trial protocols with prospectivetrial sites; ·clinical trials of our product candidates may produce negative or inconclusive results, and we may decide, or regulators may require us,to conduct additional clinical trials or abandon product development programs; ·the number of patients required for clinical trials of our product candidates may be larger than we anticipate; enrollment in these clinicaltrials may be slower than we anticipate, clinical sites may drop out of our clinical trials or participants may drop out of these clinicaltrials at a higher rate than we anticipate; ·our third-party contractors may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner,or at all; ·regulators or institutional review boards may require that we or our investigators suspend or terminate clinical research for variousreasons, including noncompliance with regulatory requirements or a finding that the participants are being exposed to unacceptablehealth risks due to serious and unexpected side effects; ·the cost of clinical trials of our product candidates may be greater than we anticipate; ·the FDA or comparable foreign regulatory authorities could require that we perform more studies than, or evaluate clinical endpointsother than, those that we currently expect; and ·the supply or quality of our product candidates or other materials necessary to conduct clinical trials of our product candidates may beinsufficient or inadequate.If we are required to conduct additional clinical trials or other testing of our product candidates beyond those that we currently contemplate, if weare unable to successfully complete clinical trials of our product candidates or other testing, if the results of these trials or tests are not positive orare only modestly positive or if there are safety concerns, we may: ·be delayed in obtaining marketing approval for our product candidates; ·not obtain marketing approval at all; ·obtain approval for indications or patient populations that are not as broad as intended or desired; ·obtain approval with labeling that includes significant use or distribution restrictions or safety warnings, including boxed warnings; ·be subject to additional post-marketing testing requirements; or ·have the product removed from the market after obtaining marketing approval.Product development costs will also increase if we experience delays in testing or in receiving marketing approvals. We do not know whether anyclinical trials will begin as planned, will need to be restructured or will be completed on schedule, or at all. Significant clinical trial delays also couldshorten any periods during which we may have the exclusive right to commercialize our product candidates, could allow our competitors to bringproducts to market before we do, and could impair our ability to successfully commercialize our product candidates, any of which may harm ourbusiness and results of operations.We may not be successful in our efforts to use and expand our Cloudbreak immunotherapy platform to build a pipeline of productcandidates.A key element of our strategy is to use and expand our Cloudbreak immunotherapy platform to build a pipeline of development candidates andprogress these through clinical development for the treatment of a wide variety of infectious diseases, including bacterial and viral infections. Todate, the only development candidates that we have identified from the platform are antifungals, and they are in very early preclinical testing. Evenif we are29CIDARA THERAPEUTICS, INC. successful in continuing to build our pipeline, the potential development candidates that we identify may not be suitable for clinical development,including as a result of being shown to have harmful side effects or other characteristics that indicate that they are unlikely to be products that willreceive marketing approval and achieve market acceptance. If we do not continue to successfully develop and eventually commercialize products,we will face difficulty in obtaining product revenues in future periods, which could result in significant harm to our financial position and adverselyaffect our share price.If we experience delays or difficulties in enrolling patients in clinical trials, our receipt of necessary regulatory approvals could bedelayed or prevented.We may not be able to initiate or continue clinical trials for our product candidates if we are unable to identify and enroll a sufficient number ofeligible patients to participate in these trials as required by the FDA or analogous regulatory authorities outside the United States. In addition,some of our competitors may have ongoing clinical trials for product candidates that would treat the same indications as our product candidates,and patients who would otherwise be eligible for our clinical trials may instead enroll in clinical trials of our competitors’ product candidates. Patientenrollment is also affected by other factors, including: ·severity of the disease under investigation; ·availability and efficacy of approved medications for the disease under investigation; ·eligibility criteria for the trial in question; ·perceived risks and benefits of the product candidate under study; ·efforts to facilitate timely enrollment in clinical trials; ·reluctance of physicians to encourage patient participation in clinical trials; ·the ability to monitor patients adequately during and after treatment; and ·proximity and availability of clinical trial sites for prospective patients.Our inability to enroll a sufficient number of patients for our clinical trials would result in significant delays or may require us to abandon one ormore clinical trials altogether. Enrollment delays in our clinical trials may result in increased development costs for our product candidates, whichwould cause the value of our company to decline and limit our ability to obtain additional financing.If serious adverse effects or unexpected characteristics of our product candidates are identified during development, we may need toabandon or limit our development of some or all of our product candidates.All of our programs are in preclinical development or are in the early stages of clinical development and their risk of failure is high. It is impossibleto predict when or if any of our product candidates will prove effective or safe in humans or will receive marketing approval. If our productcandidates are associated with undesirable side effects or have characteristics that are unexpected, we may need to abandon their developmentor limit development to certain uses or subpopulations in which the undesirable side effects or other characteristics are less prevalent, less severeor more acceptable from a risk-benefit perspective. For example, the pharmacokinetic properties, such as a longer half-life, that differentiateCD101 IV from other echinocandins could have side effects that we have not anticipated and the consequences of such side effects could bemore severe than has been seen with other echinocandins that have shorter half-lives or are dosed at lower concentrations than we expect forCD101 IV. Additionally, CD101 topical is the first application of an echinocandin antifungal as a topical treatment and may have side effectsrelated to the method of treatment delivery that are unexpected and different from those of other echinocandin antifungals. Further, the treatmentadvantages that we are predicting for CD101 IV, such as lower healthcare costs resulting from an ability to administer CD101 IV once-weekly orthe predicted ability of CD101 IV to be effective against resistant strains of fungal pathogens, may not be realized.In the biotechnology industry, many agents that initially show promise in early stage testing may later be found to cause side effects that preventfurther development of the agent. In addition, fungal infections can occur in patients with co-morbidities and weakened immune systems, and theremay be adverse events and deaths in our clinical trials that are attributable to factors other than investigational use of our product candidates.30CIDARA THERAPEUTICS, INC. We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidatesor indications that may be more profitable or for which there is a greater likelihood of success.We have limited financial resources. As a result, we may forego or delay pursuit of opportunities with other product candidates or for otherindications that later prove to have greater commercial potential. Our resource allocation decisions may cause us to fail to capitalize on viablecommercial products or profitable market opportunities. Our spending on current and future research and development programs and productcandidates for specific indications may not yield any commercially viable products. If we do not accurately evaluate the commercial potential ortarget market for a particular product candidate, we may relinquish valuable rights to that product candidate through collaboration, licensing or otherroyalty arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights tosuch product candidate.Even if any of our product candidates receive marketing approval, they may fail to achieve the degree of market acceptance byphysicians, patients, third-party payors and others in the medical community necessary for commercial success.If any of our product candidates receive marketing approval, they may nonetheless fail to gain sufficient market acceptance by physicians,patients, third-party payors and others in the medical community for us to achieve commercial success. If our product candidates do not achievean adequate level of acceptance, we may not generate significant product revenue to become profitable. The degree of market acceptance of ourproduct candidates, if approved for commercial sale, will depend on a number of factors, including: ·the efficacy and potential advantages compared to alternative treatments; ·the terms of any approvals and the countries in which approvals are obtained; ·limitations or warnings contained in any labeling approved by the FDA or other regulatory agency; ·our ability to offer any approved products for sale at competitive prices; ·convenience and ease of administration compared to alternative treatments; ·the willingness of the target patient population to try new therapies or dosing regimens; ·the willingness of physicians to prescribe these therapies and, in the case of CD101 IV, transition to a once-weekly dosing regimen fromtraditional once-daily dosing; ·the strength of marketing and distribution support; ·the success of competing products and the marketing efforts of our competitors; ·sufficient third-party coverage and adequate reimbursement; and ·the prevalence and severity of any side effects.If, in the future, we are unable to establish sales and marketing capabilities or to selectively enter into agreements with third parties tosell and market our product candidates, we may not be successful in commercializing our product candidates if and when they areapproved.We do not have a sales or marketing infrastructure and have no experience in the sale, marketing or distribution of pharmaceutical products. Toachieve commercial success for any approved product for which we retain sales and marketing responsibilities, we must either develop a salesand marketing organization or outsource these functions to other third parties. In the future, we may choose to build a focused sales and marketinginfrastructure to sell some of our product candidates if and when they are approved.There are risks involved both with establishing our own sales and marketing capabilities and with entering into arrangements with third parties toperform these services. For example, recruiting and training a sales force is expensive and time consuming and could delay any product launch. Ifthe commercial launch of a product candidate for which we recruit a sales force and establish marketing capabilities is delayed or does not occurfor any reason, we would have prematurely or unnecessarily incurred these commercialization expenses. This may be costly, and our investmentwould be lost if we cannot retain or reposition our sales and marketing personnel.31CIDARA THERAPEUTICS, INC. Factors that may inhibit our efforts to commercialize our product candidates on our own include: ·our inability to recruit and retain adequate numbers of effective sales and marketing personnel; ·the inability of sales personnel to obtain access to physicians or to achieve adequate numbers of prescriptions for any future products;and ·unforeseen costs and expenses associated with creating an independent sales and marketing organization.If we enter into arrangements with third parties to perform sales, marketing and distribution services, our product revenue or the profitability ofthese product revenues to us may be lower than if we were to market and sell any products that we develop ourselves. In addition, we may not besuccessful in entering into arrangements with third parties to sell and market our product candidates or may be unable to do so on terms that arefavorable to us. We may have little control over such third parties, and any of them may fail to devote the necessary resources and attention tosell and market our products effectively. If we do not establish sales and marketing capabilities successfully, either on our own or in collaborationwith third parties, we will not be successful in commercializing our product candidates.We face substantial competition, which may result in others discovering, developing or commercializing products before or moresuccessfully than we do.The development and commercialization of new drug products is highly competitive. We face competition with respect to our current productcandidates, and will face competition with respect to any product candidates that we may seek to develop or commercialize in the future, frommajor pharmaceutical companies, specialty pharmaceutical companies and biotechnology companies worldwide. Regulatory incentives to developdrugs for treatment of infectious diseases have increased interest and activity in this area and will lead to increased competition for clinicalinvestigators and clinical trial subjects, as well as for future prescriptions, if any of our product candidates are successfully developed andapproved. There are a number of large pharmaceutical and biotechnology companies that currently market and sell products or are pursuing thedevelopment of products for the treatment of the indications on which we are focusing our product development efforts. Some of these competitiveproducts and therapies are based on scientific approaches that are the same as or similar to our approach and others are based on entirelydifferent approaches. Potential competitors also include academic institutions, government agencies and other public and private researchorganizations that conduct research, seek patent protection and establish collaborative arrangements for research, development, manufacturingand commercialization.CD101 IV will primarily compete with antifungal classes for the treatment of candidemia, which include polyenes, azoles and echinocandins. Theapproved branded therapies for this indication include Cancidas (caspofungin, marketed by Merck & Co.), Eraxis (anidulafungin, marketed byPfizer, Inc.) and Mycamine (micafungin, marketed by Astellas Pharma US, Inc.). In addition, there are other generic products approved forcandidemia, marketed by companies such as Baxter Healthcare Corporation, Mylan Inc. and Glenmark Generics Inc., among others. In addition toapproved therapies, we expect that CD101 IV will compete with product candidates that we are aware of in clinical development by third parties,including SCY-078 (being developed by Scynexis, Inc.) and Cresemba (isavuconazole, being developed for the treatment of candidemia jointly byAstellas Pharma Inc. and Basilea Pharmaceutica Ltd.).CD101 topical will primarily compete against azole agents (oral, topical and intravaginal), currently used in the treatment of VVC, as well as over-the-counter topical agents used to treat these conditions. The approved prescription therapies for VVC are Diflucan (fluconazole) and Terazol(terconazole). Several over-the-counter topical agents such as Monistat (miconazole), Gyne-Lotrimin (clotrimazole) or Gynazole-1 (butoconazole)are also used to treat VVC. In addition to approved therapies, we expect that CD101 topical will compete with product candidates that we areaware of in clinical development by third parties, including VT-1161 (being developed by Viamet Pharmaceuticals, Inc.), SCY-078 (being developedby Scynexis, Inc.), and albaconazole (being developed by Actavis plc).We intend to develop product candidates from our Cloudbreak immunotherapy platform for the treatment of invasive fungal infection. The approvedbranded therapies for invasive fungal infection are Vfend (voriconazole, marketed by Pfizer, Inc.), AmBisome (amphotericin B liposome, market byAstellas Pharma Inc. and Gilead Sciences, Inc.), and Cresemba (isavuconazole, marketed by Basilea Pharmaceutica Ltd. and Pfizer Inc.). There32CIDARA THERAPEUTICS, INC. are other generic products approved for the treatment of invasive fungal infection marketed by companies such as Sandoz (a Novartis Company),Teva Pharmaceutical Industries Ltd. and Glenmark Generics Inc., among others.Our competitors may develop products that are more effective, safer, more convenient or less costly than any that we are developing or that wouldrender our product candidates obsolete or non-competitive. Our competitors may also obtain marketing approval from the FDA or other regulatoryauthorities for their products sooner than we may obtain approval for ours, which could result in our competitors establishing a strong marketposition before we are able to enter the market.Many of our competitors have significantly greater name recognition, financial resources and expertise in research and development,manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals and marketing approved products than we do. Mergersand acquisitions in the pharmaceutical and biotechnology industries may result in even more resources being concentrated among a smallernumber of our competitors. Smaller and other early stage companies may also prove to be significant competitors, particularly throughcollaborative arrangements with large and established companies. These same competitors may invent technology that competes with ourCloudbreak immunotherapy platform.These third parties may compete with us in recruiting and retaining qualified scientific and management personnel, establishing clinical trial sitesand patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs.Even if we are able to commercialize any product candidates, these products may become subject to unfavorable pricing regulations,third-party reimbursement practices or healthcare reform initiatives, which would harm our business.The regulations that govern marketing approvals, pricing and reimbursement for new drugs vary widely from country to country. In the UnitedStates, new and future legislation may significantly change the approval requirements in ways that could involve additional costs and cause delaysin obtaining approvals. Some countries require approval of the sale price of a drug before it can be marketed. In many countries, the pricing reviewperiod begins after marketing or product-licensing approval is granted. In some foreign markets, prescription pharmaceutical pricing remainssubject to continuing governmental control even after initial marketing approval is granted. As a result, we might obtain marketing approval for adrug in a particular country, but then be subject to price regulations that delay its commercial launch, possibly for lengthy time periods, andnegatively impact the revenue we are able to generate from the sale of the drug in that country. Adverse pricing limitations may hinder our ability tocommercialize and generate revenue from one or more product candidates, even if our product candidates obtain marketing approval.Our ability to commercialize any product candidates successfully also will depend in part on the extent to which coverage and adequatereimbursement for these products and related treatments will be available from government health programs, private health insurers and other third-party payors. Third-party payors decide which medications they will pay for and establish reimbursement levels. A significant trend in the U.S.healthcare industry and elsewhere is cost containment. Government authorities and third-party payors have attempted to control costs by limitingcoverage and the amount of payment for particular medications. Increasingly, third-party payors are requiring that drug companies providepredetermined discounts from list prices and are challenging the prices charged for medical products. Coverage and reimbursement may not beavailable for any product that we commercialize and, if reimbursement is available, the level of reimbursement may not be sufficient. Coverageand reimbursement may impact the demand for, or the price of, any product candidate for which we obtain marketing approval. If coverage andreimbursement is not available or is available only to limited levels, we may not be able to successfully commercialize any product candidate forwhich we obtain marketing approval.There may be significant delays in obtaining coverage and adequate reimbursement for newly approved products, and coverage may be morelimited than the purposes for which the product is approved by the FDA or similar regulatory authorities outside the United States. Moreover,eligibility for coverage and reimbursement does not imply that any product will be paid for in all cases or at a rate that covers our costs, includingresearch, development, manufacture, sale and distribution. Interim reimbursement levels for new drugs, if applicable, may also not be sufficient tocover our costs and may not be made permanent. Coverage and reimbursement rates may vary according to the use of the drug and the medicalcircumstances under which it is used, may be based on reimbursement levels already set for lower cost products or procedures or may beincorporated into existing33CIDARA THERAPEUTICS, INC. payments for other services. Net prices for drugs may be reduced by mandatory discounts or rebates required by government healthcare programsor private payors and by any future relaxation of laws that presently restrict imports of drugs from countries where they may be sold at lower pricesthan in the United States. Commercial third-party payors often rely upon Medicare coverage policies and payment limitations in setting their ownreimbursement policies. Our inability to promptly obtain coverage and profitable payment rates from both government-funded programs and privatepayors for any approved products that we develop could have a material adverse effect on our operating results, our ability to raise capital neededto commercialize our approved products and our overall financial condition.Product liability lawsuits against us could cause us to incur substantial liabilities and could limit the commercialization of any productcandidates we may develop.We face an inherent risk of product liability exposure related to the testing of our product candidates in human clinical trials and will face an evengreater risk if we commercially sell any products that we may develop after approval. If we cannot successfully defend ourselves against claimsthat our product candidates caused injuries, we could incur substantial liabilities. Regardless of merit or eventual outcome, liability claims mayresult in: ·decreased demand for any product candidates that we may develop; ·injury to our reputation and significant negative media attention; ·withdrawal of clinical trial participants; ·significant costs to defend any related litigation; ·substantial monetary awards to trial participants or patients; ·loss of revenue; and ·the inability to commercialize any products we may develop.Although we have product liability insurance for our clinical trials, such insurance may not be adequate to cover all liabilities that we may incur. Weanticipate that we will need to increase our insurance coverage as we continue clinical trials and if we successfully commercialize any products.Insurance coverage is increasingly expensive. We may not be able to maintain insurance coverage at a reasonable cost or in an amount adequateto satisfy any liability that may arise.If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incurcosts that could harm our business.We are subject to numerous environmental, health and safety laws and regulations, including those governing laboratory procedures and thehandling, use, storage, treatment and disposal of hazardous materials and wastes. Our operations involve the use of hazardous and flammablematerials, including chemicals and biological and radioactive materials. Our operations also produce hazardous waste products. We generallycontract with third parties for the disposal of these materials and wastes. We cannot eliminate the risk of contamination or injury from thesematerials. In the event of contamination or injury resulting from our use of hazardous materials, we could be held liable for any resulting damages,and any liability could exceed our resources. We also could incur significant costs associated with civil or criminal fines and penalties.Although we maintain workers’ compensation insurance to cover us for costs and expenses we may incur due to injuries to our employees in ourworkplace, including those resulting from the use of hazardous materials, this insurance may not provide adequate coverage against potentialliabilities. We do not maintain insurance for environmental liability or toxic tort claims that may be asserted against us in connection with ourstorage or disposal of biological, chemical, hazardous or radioactive materials.In addition, we may incur substantial costs in order to comply with current or future environmental, health and safety laws and regulations. Thesecurrent or future laws and regulations may impair our research, development or production efforts. Failure to comply with these laws andregulations also may result in substantial fines, penalties or other sanctions.34CIDARA THERAPEUTICS, INC. We may not be successful in our efforts to identify, discover, in-license or acquire potential product candidates.Our Cloudbreak immunotherapy platform and other drug discovery efforts may not be successful in identifying molecules that could be developedas drug therapies. Our research programs may initially show promise in identifying potential product candidates, yet fail to yield product candidatesfor clinical development for a number of reasons. In particular, our research methodology used may not be successful in identifying compoundswith sufficient potency or bioavailability to be potential product candidates. In addition, our potential product candidates may, on further study, beshown to have harmful side effects or other negative characteristics.Research programs to identify new product candidates require substantial technical, financial and human resources. We may choose to focus ourefforts and resources on potential product candidates that ultimately prove to be unsuccessful. If we are unable to identify, in-license or acquiresuitable compounds for preclinical and clinical development, we will not be able to generate product revenue, which would harm our financialposition and adversely impact our stock price. To date, we have not in-licensed any such compounds.Risks Related to Our Dependence on Third PartiesWe intend to continue to rely on third parties to conduct our clinical trials and to conduct some aspects of our research and preclinicaltesting, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials,research or testing.We current rely and expect to continue to rely on third parties, such as contract research organizations, clinical data management organizations,medical institutions and clinical investigators, to conduct our clinical trials and to conduct some aspects of our research and preclinical testing.Any of these third parties may terminate their engagements with us at any time. If these third parties do not successfully carry out theircontractual duties, meet expected deadlines or conduct our clinical trials in accordance with regulatory requirements or our stated protocols, wewill not be able to obtain, or may be delayed in obtaining, marketing approvals for our product candidates and will not be able to, or may be delayedin our efforts to, successfully commercialize our product candidates. Furthermore, these third parties may also have relationships with otherentities, some of which may be our competitors. If we need to enter into alternative arrangements, it would delay our product developmentactivities.Our reliance on these third parties for research and development activities will reduce our control over these activities but will not relieve us of ourresponsibilities. For example, we will remain responsible for ensuring that each of our clinical trials is conducted in accordance with the generalinvestigational plan and protocols for the trial. Moreover, the FDA requires us to comply with standards, commonly referred to as Good ClinicalPractices, for conducting, recording and reporting the results of clinical trials to assure that data and reported results are credible and accurate andthat the rights, integrity and confidentiality of trial participants are protected. We also are required to register ongoing clinical trials and post theresults of completed clinical trials on a government-sponsored database, available at www.clinicaltrials.gov, within certain timeframes. Failure todo so can result in fines, adverse publicity and civil and criminal sanctions.We have no experience manufacturing product candidates on a clinical or commercial scale and will be dependent on third parties forthe manufacture of our product candidates. If we experience problems with any of these third parties, they could delay our clinicaldevelopment or marketing approval of our product candidates.We do not have any manufacturing facilities. We currently rely, and expect to continue to rely, on third-party manufacturers for the manufacture ofour product candidates for preclinical studies and clinical trials and for commercial supply of any of these product candidates for which we obtainmarketing approval. We do not have a long-term supply agreement with any third-party manufacturers, and we purchase our required drug supplyon a purchase order basis.35CIDARA THERAPEUTICS, INC. We may be unable to establish agreements with third-party manufacturers or to do so on terms favorable to us. Even if we are able to establishagreements with third-party manufacturers, reliance on third-party manufacturers entails additional risks, including: ·reliance on the third party for regulatory compliance and quality assurance; ·the possible breach of the manufacturing agreement by the third party; and ·the possible termination or nonrenewal of the agreement by the third party at a time that is costly or inconvenient for us.Third-party manufacturers may not be able to comply with current U.S. Good Manufacturing Practice requirements, or cGMPs, or similar regulatoryrequirements outside the United States. Our failure, or the failure of our third-party manufacturers, to comply with applicable regulations couldresult in sanctions being imposed on us, including fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, licenserevocation, seizures or recalls of product candidates, operating restrictions and criminal prosecutions, any of which could adversely affect suppliesof our product candidates and harm our business and results of operations.Any product that we may develop may compete with other product candidates and products for access to these manufacturing facilities. There area limited number of manufacturers that operate under cGMPs and that might be capable of manufacturing for us.Any performance failure on the part of our existing or future manufacturers could delay clinical development or marketing approval. We do notcurrently have arrangements in place for redundant supply for bulk drug substances. If any one of our current contract manufacturers cannotperform as agreed, we may be required to replace that manufacturer. Although we believe that there are several potential alternative manufacturerswho could manufacture our product candidates, we may incur added costs and delays in identifying and qualifying any such replacement.Our current and anticipated future dependence upon others for the manufacture of our product candidates or products may adversely affect ourfuture profit margins and our ability to commercialize any product candidates that receive marketing approval on a timely and competitive basis.We currently rely, and expect to continue to rely, on third parties to store and distribute drug supplies for our clinical trials. Any performance failureon the part of these third parties could delay clinical development or marketing approval of our product candidates or commercialization of ourdrugs, producing additional losses and depriving us of potential revenue. Although we believe that there are several potential alternative thirdparties who could store and distribute drug supplies for our clinical trials, we may incur added costs and delays in identifying and qualifying anysuch replacement.We may seek to selectively establish collaborations, and, if we are unable to establish them on commercially reasonable terms or at all,we may have to alter our development and commercialization plans.Our drug development programs and the potential commercialization of our product candidates will require substantial additional cash to fundexpenses. For some of our product candidates, we may decide to collaborate with other pharmaceutical and biotechnology companies for thedevelopment and potential commercialization of those product candidates. We do not currently have any such collaborations.We face significant competition in seeking appropriate collaborators. Whether we reach a definitive agreement for a collaboration will depend,among other things, upon our assessment of the collaborator’s resources and expertise, the terms and conditions of the proposed collaborationand the proposed collaborator’s evaluation of a number of factors.Those factors may include: ·the design or results of clinical trials; ·the likelihood of approval by the FDA or similar regulatory authorities outside the United States; ·the potential market for the subject product candidate;36CIDARA THERAPEUTICS, INC. ·the costs and complexities of manufacturing and delivering such product candidate to patients; ·the potential of competing products; ·the existence of uncertainty with respect to our ownership of technology, which can exist if there is a challenge to such ownershipwithout regard to the merits of the challenge; and ·industry and market conditions generally.The collaborator may also consider alternative product candidates for similar indications that may be available to collaborate on and whether sucha collaboration could be more attractive than the one with us for our product candidate.To the extent we enter into any collaborations, we may depend on collaborators for the development and commercialization of ourproduct candidates. If those collaborations are not successful, we may not be able to capitalize on the market potential of our productcandidates.We may selectively seek third-party collaborators for the development and commercialization of our product candidates. Our likely collaborators forany collaboration arrangements include large and mid-size pharmaceutical companies, regional and national pharmaceutical companies andbiotechnology companies. We do not currently have any such arrangements and if we enter into any such arrangements with any third parties inthe future, we will likely have limited control over the amount and timing of resources that our collaborators dedicate to the development orcommercialization of our product candidates. Our ability to generate revenue from these arrangements will depend on our collaborators’ abilities tosuccessfully perform the functions assigned to them in these arrangements.Collaborations involving our product candidates pose many risks to us, including that: ·collaborators have significant discretion in determining the efforts and resources that they will apply to these collaborations; ·collaborators may not pursue development and commercialization of our product candidates or may elect not to continue or renewdevelopment or commercialization programs based on clinical trial results, changes in the collaborator’s strategic focus or availablefunding or external factors such as an acquisition that diverts resources or creates competing priorities; ·collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a productcandidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing; ·collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our productcandidates or products if the collaborators believe that competitive products are more likely to be successfully developed or can becommercialized under terms that are more economically attractive than ours; ·a collaborator with marketing and distribution rights to one or more product candidates or products may not commit sufficient resourcesto the marketing and distribution of such drugs; ·collaborators may not properly maintain or defend our intellectual property rights or may use our proprietary information in such a way asto invite litigation that could jeopardize or invalidate our proprietary information or expose us to potential litigation; ·disputes may arise between the collaborators and us that result in the delay or termination of the research, development orcommercialization of our product candidates or products or that result in costly litigation or arbitration that diverts management attentionand resources; ·we may lose certain valuable rights under circumstances identified in our collaborations if we undergo a change of control; ·collaborations may be terminated and, if terminated, may result in a need for additional capital to pursue further development orcommercialization of the applicable product candidates;37CIDARA THERAPEUTICS, INC. ·collaboration agreements may not lead to development or commercialization of product candidates in the most efficient manner or at all;and ·if a future collaborator of ours were to be involved in a business combination, the continued pursuit and emphasis on our productdevelopment or commercialization program under such collaboration could be delayed, diminished or terminated.Risks Related to Regulatory Approval of Our Product Candidates and Other Legal Compliance MattersFor CD101 IV, we may not be eligible for, have not yet requested, and may not be able to obtain, breakthrough therapy designation oraccelerated approval from the FDA. For CD101 topical and any Cloudbreak development candidates, we have not yet requested, and maynot be able to obtain, Qualified Infectious Disease Product, or QIDP, fast track, breakthrough therapy or orphan drug designations oraccelerated approval from the FDA. There are a number of incentive programs that the FDA administers to facilitate development of drugs in areas of unmet medical need. We haveno human clinical data on any of our product candidates, and with the exception of CD101 IV, which received designation as a QIDP, Fast Trackproduct, and Orphan Drug, none of them may qualify under any of the FDA’s existing or future programs to expedite drug development in areas ofunmet medical need. Without access to such benefits, we may require more time, larger trials and incur greater expense in the development of ourproduct candidates.If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals, we will not be able to commercialize, orwill be delayed in commercializing, our product candidates, and our ability to generate revenue will be impaired.Our product candidates and the activities associated with their development and commercialization, including their design, testing, manufacture,safety, efficacy, recordkeeping, labeling, storage, approval, advertising, promotion, sale and distribution, are subject to comprehensive regulationby the FDA and other regulatory agencies in the United States and by comparable authorities in other countries. For example, in order tocommence clinical trials of our product candidates in the United States, we must file an IND. The FDA may place our development program onclinical hold and require further preclinical testing prior to allowing our clinical trials to proceed. In addition, although we anticipate that our INDsubmission for CD101 topical will be supported by our preclinical testing of CD101 IV, the FDA may not view such tests as supportive.We must obtain marketing approval in each jurisdiction in which we market our products. Failure to obtain marketing approval for a productcandidate will prevent us from commercializing the product candidate. We have not received approval to market any of our product candidatesfrom regulatory authorities in any jurisdiction. We have only limited experience in filing and supporting the applications necessary to gain marketingapprovals and expect to rely on third-party contract research organizations to assist us in this process. Securing regulatory approval requires thesubmission of extensive preclinical and clinical data and supporting information to the various regulatory authorities for each therapeutic indicationto establish the product candidate’s safety and efficacy. Securing regulatory approval also requires the submission of information about theproduct manufacturing process to, and inspection of manufacturing facilities by, the relevant regulatory authority. Our product candidates may notbe effective, may be only moderately effective or may prove to have undesirable or unintended side effects, toxicities or other characteristics thatmay preclude our obtaining marketing approval or prevent or limit commercial use.The process of obtaining marketing approvals, both in the United States and elsewhere, is expensive, may take many years and can varysubstantially based upon a variety of factors, including the type, complexity and novelty of the product candidates involved. We cannot assure youthat we will ever obtain any marketing approvals in any jurisdiction. Changes in marketing approval policies during the development period,changes in or the enactment of additional statutes or regulations or changes in regulatory review for each submitted product application may causedelays in the approval or rejection of an application. The FDA and comparable authorities in other countries have substantial discretion in theapproval process and may refuse to accept any application or may decide that our data is insufficient for approval and require additional preclinicalor other studies, and clinical trials. In addition, varying interpretations of the data obtained from preclinical testing and clinical trials could delay,limit or prevent marketing approval of a product candidate. Additionally, any marketing approval we ultimately obtain may be38CIDARA THERAPEUTICS, INC. limited or subject to restrictions or post-approval commitments that render the approved product not commercially viable.Any product candidate for which we obtain marketing approval could be subject to marketing restrictions or withdrawal from the market,and we may be subject to penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with ourproducts.Any product candidate for which we obtain marketing approval, along with the manufacturing processes, post-approval clinical data, labeling,advertising and promotional activities for such product, will be subject to continual requirements of and review by the FDA and other regulatoryauthorities. These requirements include submissions of safety and other post-marketing information and reports, registration and listingrequirements, cGMP requirements, quality assurance and corresponding maintenance of records and documents and requirements regarding thedistribution of samples to physicians and recordkeeping. Even if marketing approval of a product candidate is granted, the approval may besubject to limitations on the indicated uses for which the product may be marketed or to the conditions of approval, or contain requirements forcostly post-marketing testing and surveillance to monitor the safety or efficacy of the medicine. The FDA closely regulates the post-approvalmarketing and promotion of drugs to ensure that they are marketed only for the approved indications and in accordance with the provisions of theapproved labeling. The FDA imposes stringent restrictions on manufacturers’ communications regarding off-label use and if we do not market ourproducts for their approved indications, we may be subject to enforcement action for off-label marketing.In addition, later discovery of previously unknown problems with our products, manufacturers or manufacturing processes, or failure to comply withregulatory requirements, may result in, among other things: ·restrictions on such products, manufacturers or manufacturing processes; ·restrictions on the labeling, marketing, distribution or use of a product; ·requirements to conduct post-approval clinical trials; ·warning or untitled letters; ·withdrawal of the products from the market; ·refusal to approve pending applications or supplements to approved applications that we submit; ·recall of products; ·fines, restitution or disgorgement of profits or revenue; ·suspension or withdrawal of marketing approvals; ·refusal to permit the import or export of our products; ·product seizure; and ·injunctions or the imposition of civil or criminal penalties.Our relationships with customers, health care professionals and third-party payors will be subject to applicable healthcare laws, whichcould expose us to penalties, including administrative, civil, criminal penalties, damages, fines, imprisonment, exclusion fromparticipation in federal healthcare programs, such as Medicare and Medicaid, as well as contractual damages, reputational harm anddiminished profits and future earnings.Healthcare professionals and third-party payors play a primary role in the recommendation and prescription of any product candidates for which weobtain marketing approval. Our future arrangements with customers, healthcare professionals and third-party payors may expose us to broadlyapplicable fraud and abuse and other healthcare laws and regulations that may constrain the business or financial arrangements and relationshipsthrough which we market, sell and distribute our medicines for which we obtain marketing approval. Restrictions under applicable federal and statehealthcare laws and regulations include the following: ·the federal healthcare anti-kickback statute prohibits, among other things, persons and entities from, among other things, knowingly andwillfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward either thereferral of an individual for, or the39CIDARA THERAPEUTICS, INC. purchase, lease, order or recommendation of, any good, facility, item or service, for which payment may be made under federal andstate healthcare programs such as Medicare and Medicaid; ·the federal false claims laws impose criminal and civil penalties, including civil whistleblower or qui tam actions under the federal CivilFalse Claims Act, against individuals or entities for, among other things, knowingly presenting, or causing to be presented, to the federalgovernment, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation topay money to the federal government; ·HIPAA, as amended by HITECH, imposes criminal and civil liability for, among other things, executing a scheme to defraud anyhealthcare benefit program and also imposes obligations, including mandatory contractual terms, with respect to safeguarding theprivacy, security and transmission of individually identifiable health information; ·the federal false statements statute enacted under HIPAA prohibits knowingly and willfully falsifying, concealing or covering up amaterial fact or making any materially false statement in connection with the delivery of or payment for healthcare benefits, items orservices; ·the federal transparency requirements under the Affordable Care Act requires, among other things, certain manufacturers of drugs,devices, biologics and medical supplies to report annually to the Department of Health and Human Services information related tophysician payments and other transfers of value and physician ownership and investment interests; and ·analogous state laws and regulations, such as state anti-kickback and false claims laws, may apply to our business activities, includingsales or marketing arrangements and claims involving healthcare items or services including, in some states, those reimbursed by non-governmental third-party payors, including private insurers, and some state laws require pharmaceutical companies to comply with thepharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal governmentin addition to requiring drug manufacturers to report information related to payments or other transfers of value provided to physiciansand other health care providers and entities or marketing expenditures.Efforts to ensure that our business arrangements with third parties will comply with applicable healthcare laws and regulations will involvesubstantial costs. It is possible that governmental authorities will conclude that our business practices may not comply with current or futurestatutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations. If our operations are found to be inviolation of any of these laws or any other governmental laws that may apply to us, we may be subject to significant civil, criminal andadministrative penalties, damages, fines, exclusion from government funded healthcare programs, such as Medicare and Medicaid, imprisonmentand the curtailment or restructuring of our operations. If any of the physicians or other providers or entities with whom we expect to do businessare found to be not in compliance with applicable laws, they may be subject to criminal, civil or administrative sanctions, including exclusions fromgovernment funded healthcare programs.Recently enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercializeour product candidates and affect the prices we may obtain.In the United States and some foreign jurisdictions, there have been a number of legislative and regulatory changes and proposed changesregarding the healthcare system that could prevent or delay marketing approval of our product candidates, restrict or regulate post-approvalactivities and affect our ability to profitably sell any product candidates for which we obtain marketing approval.For example, in March 2010, President Obama signed into law the Affordable Care Act, a sweeping law intended to, among other things, broadenaccess to health insurance, reduce or constrain the growth of healthcare spending, enhance remedies against fraud and abuse, add newtransparency requirements for health care and health insurance industries, impose new taxes and fees on the health industry and imposeadditional health policy reforms. The Affordable Care Act and subsequent regulations revised the definition of “average manufacturer price” forreporting purposes, which could increase the amount of Medicaid drug rebates to states. Further, the new law imposes a significant annual fee oncompanies that manufacture or import branded prescription drug products. Substantial new provisions affecting compliance have also beenenacted, which may affect our business practices with health care practitioners. Since its enactment there have been judicial and Congressional40CIDARA THERAPEUTICS, INC. challenges to certain aspects of the Affordable Care Act, and we expect there will be additional challenges and amendments to it in the future.Although the full effect of the Affordable Care Act remains uncertain, the law appears likely to continue the pressure on pharmaceutical pricing,especially under the Medicare program, and may also increase our regulatory burdens and operating costs.Legislative and regulatory proposals have been made to expand post-approval requirements and restrict sales and promotional activities forpharmaceutical products. In addition, there have been several recent Congressional inquiries and proposed bills designed to, among other things,bring more transparency to drug pricing, review the relationship between pricing and manufacturer patient programs, and reform governmentprogram reimbursement methodologies for drug products. We cannot be sure whether additional legislative changes will be enacted, or whether theFDA regulations, guidance or interpretations will be changed, or what the impact of such changes on the marketing approvals of our productcandidates, if any, may be. In addition, increased scrutiny by the U.S. Congress of the FDA’s approval process may significantly delay or preventmarketing approval, as well as subject us to more stringent product labeling and post-marketing testing and other requirements.We expect that additional healthcare reform measures will be adopted within and outside the United States in the future, any of which could limitthe amounts that governments will pay for healthcare products and services, which could result in reduced demand for our product candidates oradditional pricing pressures. The continuing efforts of third-party payors to contain or reduce costs of healthcare may adversely affect the demandfor any drug products for which we may obtain regulatory approval, our ability to set a price that we believe is fair for our products, our ability toobtain coverage and reimbursement approval for a product, our ability to generate revenues and achieve or maintain profitability, and the level oftaxes that we are required to pay.Risks Related to Our Intellectual PropertyIf our efforts to protect the proprietary nature of the intellectual property related to CD101 IV, CD101 topical or our other productcandidates are not adequate, we may not be able to compete effectively in our market.We rely upon a combination of patents, trademarks, trade secret protection and confidentiality agreements to protect the intellectual propertyrelated to CD101 IV, CD101 topical and our other product candidates, including our Cloudbreak immunotherapy platform. Any involuntarydisclosure to or misappropriation by third parties of our confidential proprietary information could enable competitors to quickly duplicate or surpassour technological achievements, thus eroding our competitive position in our market.The strength of patents in the biotechnology and pharmaceutical field involves complex legal and scientific questions and can be uncertain and ourcommercial success will depend on our ability to obtain patents and maintain adequate protection for CD101 IV, CD101 topical and other productcandidates in the United States and other countries. We currently hold issued U.S. utility and foreign patents, and multiple pending U.S. utilitypatent applications, pending U.S. provisional patent applications, and pending international, foreign national and regional counterpart patentapplications covering various aspects of CD101 IV, CD101 topical, our Cloudbreak immunotherapy platform, and other technology. The patentapplications may fail to result in issued patents in the United States or in foreign countries or jurisdictions. Even if the applications do successfullyissue, third parties may challenge the patents.Further, the existing and/or future patents, if any, may be too narrow to prevent third parties from developing or designing around these patents. Ifthe sufficiency of the breadth or strength of protection provided by the patent and patent applications we own with respect to CD101 IV, CD101topical or the patents we pursue related to any of our other product candidates is threatened, it could dissuade companies from collaborating withus to develop, and threaten our ability to commercialize CD101 IV, CD101 topical and our other product candidates. Further, if we encounterdelays in our clinical trials, the period of time during which we could market our product candidates under patent protection would be reduced,although a patent term extension or supplementary protection certificate may be available in certain jurisdictions and having varied scope tocompensate for some of the lost patent term. In addition, we do not know whether: ·we were the first to make the inventions covered by each of our pending patent applications or our issued patent; ·we were the first to file patent applications for these inventions;41CIDARA THERAPEUTICS, INC. ·others will independently develop similar or alternative technologies or duplicate any of our technologies; ·any of our pending patent applications will result in issued patents; ·any of our patents, once issued, will be valid or enforceable or will issue with claims sufficient to protect our products; ·any patents issued to us will provide us with any competitive advantages, or will be challenged by third parties; ·we will develop additional proprietary technologies that are patentable; or ·the patents of others will have an adverse effect on our business.In addition to the protection afforded by patents, we rely on trade secret protection and confidentiality agreements to protect proprietary know-howthat is not patentable, for processes for which patents are difficult to enforce and for any other elements of our drug discovery program that involveproprietary know-how, information and technology that is not covered by patents. Although we require all of our employees, consultants, advisorsand third parties who have access to our proprietary know-how, information and technology to enter into confidentiality agreements, we cannot becertain that this know-how, information and technology will not be disclosed or used in an unauthorized manner or that competitors will nototherwise gain access to our trade secrets or independently develop substantially equivalent information and techniques.There also may be challenges or other disputes concerning the inventorship, ownership, or right to use our intellectual property. For example, ourconsultants and advisors may have obligations to assign certain inventions and/or know-how that they develop to third-party entities in certaininstances, and these third parties may challenge our ownership or other rights to our intellectual property, which would adversely affect ourbusiness.An inability to obtain, enforce and defend patents covering our proprietary technologies would materially and adversely affect our businessprospects and financial condition. Further, the laws of some foreign countries do not protect proprietary rights to the same extent as the laws ofthe United States. We may encounter significant problems in protecting, enforcing, and defending our intellectual property both in the United Statesand abroad. If we are unable to prevent unauthorized material disclosure of the intellectual property related to our technologies to third parties, orare otherwise unable to protect, enforce or defend our intellectual property, we will not be able to establish or, if established, maintain a competitiveadvantage in our market, which could materially adversely affect our business, operating results and financial condition.Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee paymentand other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.Periodic maintenance fees, renewal fees, annuity fees and various other governmental fees on patents and/or applications will be due to be paid tothe United States Patent and Trademark Office, or USPTO, and various foreign or jurisdictional governmental patent agencies in several stagesover the lifetime of the patents and/or applications. We have systems in place to remind us to pay these fees, and we employ an outside firm topay these fees due to foreign patent agencies. The USPTO and various foreign governmental patent agencies require compliance with a number ofprocedural, documentary, fee payment and other similar provisions during the patent application process.We employ reputable law firms and other professionals to help us comply, and in many cases, an inadvertent lapse can be cured by payment of alate fee or by other means in accordance with the applicable rules. However, there are situations in which noncompliance can result inabandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction.Noncompliance events that could result in abandonment or lapse of a patent or patent application include, but are not limited to, failure to respondto official actions within prescribed time limits, non-payment of fees and failure to properly legalize and submit formal documents. Suchnoncompliance events are outside of our direct control for (1) non-U.S. patents and patent applications owned by us, and (2) if applicable, in thefuture, patents and patent applications licensed to us by another entity. In such an event, our competitors might be able to enter the market andthis circumstance would have a material adverse effect on our business.42CIDARA THERAPEUTICS, INC. Third-party claims of intellectual property infringement may prevent or delay our drug discovery and development efforts.Our commercial success depends in part on our avoiding infringement of the patents and proprietary rights of third parties. Third parties mayassert that we are employing their proprietary technology without authorization. There may be third-party patents with claims to materials, methodsof manufacture or methods for treatment related to the use or manufacture of CD101 IV, CD101 topical and/or our other product candidates. Ourcommercial success depends in part on our avoiding infringement of the patents and proprietary rights of third parties. If any third-party patentswere held by a court of competent jurisdiction to cover the CD101 manufacturing process, any molecules formed during the CD101 manufacturingprocess or the final CD101 products for any use thereof, the holders of any such patents may be able to block our ability to commercialize CD101IV or CD101 topical unless we obtained a license under the applicable patent or patents, or until such patents expire. These same issues and risksarise in connection with our other product candidates as well. We cannot predict whether we would be able to obtain a license on commerciallyreasonable terms, if at all. Any inability to obtain such a license under the applicable patents on commercially reasonable terms, or at all, mayhave a material adverse effect on our ability to commercialize CD101 IV, CD101 topical or any of our other product candidates until such patentsexpire.In addition, third parties may obtain patents in the future and claim that our product candidates and/or the use of our technologies infringes uponthese patents. Furthermore, parties making claims against us may obtain injunctive or other equitable relief, which could effectively block ourability to further develop and commercialize one or more of our product candidates. Defense of these claims, regardless of their merit, wouldinvolve substantial litigation expense and would be a substantial diversion of employee resources from our business. In the event of a successfulclaim of infringement against us, we may have to pay substantial damages, including treble damages and attorneys’ fees for willful infringement,obtain one or more licenses from third parties, pay royalties and/or redesign our infringing products, which may be impossible and/or requiresubstantial time and monetary expenditure. In addition, even in the absence of litigation, we may need to obtain licenses from third parties toadvance our research or allow commercialization of CD101 IV, CD101 topical or any of our other product candidates. We may fail to obtain any ofthese licenses at a reasonable cost or on reasonable terms, if at all. In that event, we would not be able to further develop and commercialize suchproduct candidates, which could harm our business significantly.We may be required to file lawsuits or take other actions to protect or enforce our patents, which could be expensive, time consumingand unsuccessful.Competitors may infringe our current or future patents. To counter infringement or unauthorized use, we may be required to file infringementclaims, which can be expensive and time-consuming. In addition, in an infringement proceeding, a court may decide that one or more of ourasserted patents is not valid or is unenforceable, or may refuse to stop the other party from using the technology at issue on the grounds that ourpatents do not cover the technology in question. An adverse result in any litigation or defense proceedings could put one or more of our patents atrisk of being invalidated, held unenforceable, or interpreted narrowly and could put our patent applications at risk of not issuing. Pursuit of theseclaims would involve substantial litigation expense and would be a substantial diversion of employee resources from our business.Interference proceedings or derivative proceedings provoked by third parties or brought by the USPTO may be necessary to determine theentitlement to patent protection with respect to our patents or patent applications. An unfavorable outcome could result in a loss of our currentpatent rights and could require us to cease using the related technology or to attempt to license rights to it from the prevailing party. Our businesscould be harmed if the prevailing party does not offer us a license on commercially reasonable terms. Litigation or patent office proceedings mayresult in a decision adverse to our interests and, even if we are successful, may result in substantial costs and distract our management and otheremployees. We may not be able to prevent misappropriation of our trade secrets or confidential information, particularly in countries where the lawsmay not protect those rights as fully as in the United States.Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some ofour confidential information could be compromised by disclosure during this type of litigation. In addition, there could be public announcements ofthe results of hearings, motions or other interim proceedings or developments. If securities analysts or investors perceive these results to benegative, it could have a substantial adverse effect on the price of our common stock.43CIDARA THERAPEUTICS, INC. Issued patents covering our product candidates and technologies could be found invalid or unenforceable if challenged in court or theUSPTO.If we initiate legal proceedings against a third party to enforce a patent covering one of our product candidates or our technologies, the defendantcould counterclaim that the patent covering our product candidate or our technology, as applicable, is invalid and/or unenforceable. In patentlitigation in the United States, defendant counterclaims alleging invalidity and/or unenforceability are commonplace, and there are numerousgrounds upon which a third party can assert invalidity or unenforceability of a patent. Third parties may also raise similar claims beforeadministrative bodies in the United States or abroad, even outside the context of litigation. Such mechanisms include re-examination, post grantreview, and equivalent proceedings in foreign jurisdictions (e.g., opposition proceedings). Such proceedings could result in revocation oramendment to our patents in such a way that they no longer cover our product candidates or our technologies. The outcome following legalassertions of invalidity and/or unenforceability is unpredictable. With respect to the validity question, for example, we cannot be certain that thereis no invalidating prior art and that prior art that was cited during prosecution, but not relied on by the patent examiner, will not be revisited. If adefendant were to prevail on a legal assertion of invalidity and/or unenforceability, we would lose at least part, and perhaps all, of the patentprotection directed to our product candidates or technologies. Such a loss of patent rights could have a material adverse impact on our business.Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our products.As is the case with other pharmaceutical companies, our success is heavily dependent on intellectual property, particularly patents. Obtaining andenforcing patents in the pharmaceutical industry involve both technological and legal complexity, and is therefore costly, time-consuming andinherently uncertain. In addition, the United States has recently implemented wide-ranging patent reform legislation, including patent officeadministrative proceedings that offer broad opportunities to third parties to challenge issued patents. Recent U.S. Supreme Court rulings havenarrowed the scope of patent protection available in certain circumstances and weakened the rights of patent owners in certain situations. Inaddition to increasing uncertainty with regard to our ability to obtain patents in the future, this combination of events has created uncertainty withrespect to the value of patents, once obtained. Depending on decisions by the U.S. Congress, the federal courts, the USPTO, and foreigngovernmental bodies and tribunals, the laws and regulations governing patents could change in unpredictable ways that would weaken our ability toobtain new patents or to enforce our existing patent and patents that we might obtain in the future. For example, in Assoc. for Molecular Pathologyv. Myriad Genetics, Inc., the U.S. Supreme Court held in 2013 that certain claims to DNA molecules are not patentable, and lower courts havesince been applying this case in the context of other types of biological subject matter. We cannot predict how future decisions by the courts, theU.S. Congress, the USPTO, or foreign governmental bodies or tribunals may impact the value of our patent rights.We have limited foreign intellectual property rights and may not be able to protect our intellectual property rights throughout the world.We have limited intellectual property rights outside the United States. Filing, prosecuting and defending patents on product candidates in allcountries throughout the world would be prohibitively expensive, and our intellectual property rights in some countries outside the United Statescan be less extensive than those in the United States. In addition, the laws of some foreign countries do not protect intellectual property to thesame extent as federal and state laws in the United States. Consequently, we may not be able to prevent third parties from practicing ourinventions in all countries outside the United States, or from selling or importing products made using our inventions in and into the United Statesor other jurisdictions. Competitors may use our technologies in jurisdictions where we have not obtained patents to develop their own products andfurther, may export otherwise infringing products to territories where we have patents, but enforcement is not as strong as that in the UnitedStates. These products may compete with our products and our patents or other intellectual property rights may not be effective or sufficient toprevent them from competing.Many companies have encountered significant problems in protecting and defending intellectual property in foreign jurisdictions. The legal systemsof certain countries, particularly China and certain other developing countries, do not favor the enforcement of patents, trade secrets and otherintellectual property, particularly those relating to pharmaceutical products, which could make it difficult for us to stop the infringement of ourpatents or marketing of competing products in violation of our proprietary rights generally. Proceedings to enforce our patent rights in foreignjurisdictions could result in substantial costs and divert our efforts and attention from other44CIDARA THERAPEUTICS, INC. aspects of our business, could put any of our patent applications that issue into patents at risk of being invalidated or interpreted narrowly and ourpatent applications at risk of not issuing and could provoke third parties to assert claims against us. We may not prevail in any lawsuits that weinitiate and the damages or other remedies awarded, if any, may not be commercially meaningful. The requirements for patentability may differ incertain countries, particularly developing countries. Furthermore, generic drug manufacturers or other competitors may challenge the scope,validity or enforceability of any of our current or future patents, requiring us to engage in complex, lengthy and costly litigation or otherproceedings. Certain countries in Europe and developing countries, including China and India, have compulsory licensing laws under which apatent owner may be compelled to grant licenses to third parties. In those countries, we may have limited remedies if any of our patentapplications that issue into patents are infringed or if we are compelled to grant a license to a third party, which could materially diminish the valueof those patents. This could limit our potential revenue opportunities. Accordingly, our efforts to enforce our intellectual property rights around theworld may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license.If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets ofinterest and our business may be adversely affected.Our trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to be infringing on other marks. Wemay not be able to protect our rights to these trademarks and trade names or may be forced to stop using these names, which we need for namerecognition by potential partners or customers in our markets of interest. If we are unable to establish name recognition based on our trademarksand trade names, we may not be able to compete effectively and our business may be adversely affected.We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidentialinformation of third parties.We have received confidential and proprietary information from third parties. In addition, we employ individuals who were previously employed atother biotechnology or pharmaceutical companies, including our competitors or potential competitors. We may be subject to claims that we or ouremployees, consultants or independent contractors have inadvertently or otherwise used or disclosed confidential information of these third partiesor our employees’ former employers. Litigation may be necessary to defend against these claims. Even if we are successful in defending againstthese claims, litigation could result in substantial cost and be a distraction to our management and employees.Risks Related to Our Financial Position and Need For Additional CapitalWe are an early stage biotechnology company that has incurred significant operating losses since our inception and anticipate that wewill continue to incur substantial operating losses for the foreseeable future. We may never achieve or maintain profitability.Since our inception, we have incurred significant operating losses. Our net loss was $32.2 million and $11.9 million for years ended December 31,2015 and 2014, respectively. As of December 31, 2015, we had an accumulated deficit of $45.5 million. To date, we have financed our operationsprimarily through private placements of convertible preferred stock, convertible notes, and our initial public offering of our common stock. We havedevoted substantially all of our financial resources and efforts to research and development. We initiated our first clinical trial for CD101 IV in July2015, and plan to initiate the first clinical trial for CD101 topical in mid-2016. We expect that it will be many years, if ever, before we receiveregulatory approval and have a product candidate available for commercialization. We expect to continue to incur significant expenses andincreasing operating losses for the foreseeable future. Our net losses may fluctuate significantly from quarter to quarter and year to year. Weanticipate that our expenses will increase substantially if and as we: ·submit INDs to the FDA and equivalent filings to other regulatory authorities, and seek approval of our clinical protocols by institutionalreview boards, or IRBs, at clinical trial sites; ·advance CD101 IV through clinical development; ·advance CD101 topical into clinical trials; ·continue the preclinical development of product candidates from our Cloudbreak immunotherapy platform and advance a productcandidate into clinical trials;45CIDARA THERAPEUTICS, INC. ·identify additional lead candidates and advance them into preclinical development; ·seek marketing approvals for our product candidates that successfully complete clinical trials; ·establish a sales, marketing and distribution infrastructure to commercialize any product candidates for which we obtain marketingapproval; ·maintain, expand and protect our intellectual property portfolio; ·hire additional clinical, regulatory and scientific personnel; ·add operational, financial and management information systems and personnel, including personnel to support product development; and ·acquire or in-license other product candidates and technologies.To become and remain profitable, we must develop and eventually commercialize one or more products with significant market potential. This willrequire us to be successful in a range of challenging activities, including completing preclinical studies and clinical trials of our product candidates,obtaining marketing approval for these product candidates, manufacturing, marketing and selling those product candidates for which we may obtainmarketing approval, and satisfying any post-marketing requirements. We may never succeed in these activities and, even if we do, may nevergenerate revenue that is significant or large enough to achieve profitability. We have not yet initiated clinical development of any of our productcandidates. Our failure to become and remain profitable would decrease the value of the company and could impair our ability to raise capital,maintain our research and development efforts, expand our business or continue our operations. A decline in the value of our company could alsocause you to lose all or part of your investment.We will need substantial additional funding to advance the development of our product candidates. If we are unable to raise capital whenneeded, we would be forced to delay, reduce or eliminate our drug development and discovery programs or commercialization efforts.We expect our expenses to increase in connection with our ongoing activities, particularly as we continue the research and development of, initiateclinical trials of and seek marketing approval for our product candidates, initially CD101 IV and CD101 topical, and our Cloudbreak lead candidates.In addition, if we obtain marketing approval for any of our product candidates, we expect to incur significant commercialization expenses related toproduct sales, marketing, manufacturing and distribution of the approved product. Furthermore, we expect to incur additional costs associated withoperating as a public company. Our future capital requirements will depend on many factors, including: ·the scope, progress, results and costs of drug discovery, preclinical development, laboratory testing and clinical trials for our productcandidates and Cloudbreak lead candidates; ·the costs, timing and outcome of any regulatory review of our product candidates; ·the costs and timing of commercialization activities, including manufacturing, marketing, sales and distribution, for any productcandidates that receive marketing approval; ·the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defendingintellectual property-related claims; ·our ability to establish and maintain collaborations, when and if necessary, on favorable terms, if at all; and ·the extent to which we acquire or in-license other product candidates and technologies.Identifying potential development candidates and conducting preclinical studies and clinical trials are time consuming, expensive and uncertainprocesses that take years to complete, and we may never generate the necessary data or results required to obtain marketing approval andachieve product sales for any of our current or future product candidates. In addition, our product candidates, if approved, may not achievecommercial success.Our commercial revenue, if any, will be derived from sales of products that we do not expect to be commercially available for many years, if at all.46CIDARA THERAPEUTICS, INC. Accordingly, we will need substantial additional funding in connection with our continuing operations and to achieve our goals. Since December 6,2012 (inception) through December 31, 2015, our operations have been financed primarily by gross proceeds of approximately $151.0 million fromthe issuance of convertible debt securities, the sale of shares of convertible preferred stock, and the sale of shares of our common stock in ourIPO. As of December 31, 2015, we had cash, cash equivalents, and short-term investments of $107.5 million. We expect that our existing cash,cash equivalents and marketable securities and anticipated interest income will enable us to fund our operating expenses and capital expenditurerequirements through at least the next twelve months. If we are unable to raise capital when needed or on attractive terms, we would be forced todelay, reduce or eliminate our research and development programs or future commercialization efforts. Adequate additional financing may not beavailable to us on acceptable terms, or at all. In addition, we may seek additional financing due to favorable market conditions or strategicconsiderations, even if we believe we have sufficient funds for our operating plans.Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to ourtechnologies or product candidates.Until such time, if ever, as we can generate substantial product revenue, we expect to finance our cash needs through a combination of equity anddebt financings, as well as entering into collaborations, strategic alliances and licensing arrangements. We do not currently have any committedexternal source of funds. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownershipinterest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as acommon stockholder. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specificactions, such as incurring additional debt, making capital expenditures or declaring dividends, and may be secured by all or a portion of ourassets. If we raise funds by entering into collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquishvaluable rights to our technologies, future revenue streams, research programs or product candidates or to grant licenses on terms that may not befavorable to us. If we are unable to raise additional funds through equity or debt financings or through collaborations, strategic alliances or licensingarrangements when needed, we may be required to delay, limit, reduce or terminate our drug development or future commercialization efforts orgrant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.Our short operating history may make it difficult for you to evaluate the success of our business to date and assess our future viability.We were founded in December 2012 and our operations to date have been limited to organizing and staffing our company, business planning,raising capital, developing our technology, identifying potential development and product candidates, undertaking preclinical studies and, onlyrecently, initiating our first clinical trial. We have not yet demonstrated our ability to successfully complete large-scale, pivotal clinical trialsrequired for regulatory approval of our product candidates, obtain marketing approvals, manufacture a commercial scale product, or arrange for athird party to do so on our behalf, or conduct sales and marketing activities necessary for successful commercialization. Typically, it takes manyyears to develop one new product from the time it is discovered to when it is commercially available. Consequently, any predictions made aboutour future success or viability may not be as accurate as they could be if we had a longer operating history or if we had product candidates inadvanced clinical trials.In addition, as a new business, we may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown factorsthat may alter or delay our plans. We will need to transition from a company with a research focus to a company capable of supportingdevelopment activities and, if a product candidate is approved, a company with commercial activities. We may not be successful in any step insuch a transition.Risks Related to Employee Matters and Managing GrowthOur future success depends on our ability to retain our senior management team and to attract, retain and motivate qualified personnel.We are highly dependent upon our senior management team, as well as the other principal members of our research and development teams. Allof our executive officers are employed “at will,” meaning we or they may terminate the employment relationship at any time. We maintain “keyperson” insurance for our Chief Executive47CIDARA THERAPEUTICS, INC. Officer but not for any of our other executives or employees. The loss of the services of any of these persons could impede the achievement ofour research, development and commercialization objectives.Recruiting and retaining qualified scientific, clinical, manufacturing and sales and marketing personnel will also be critical to our success. We maynot be able to attract and retain these personnel on acceptable terms given the competition among numerous pharmaceutical and biotechnologycompanies for similar personnel. We also experience competition for the hiring of scientific and clinical personnel from universities and researchinstitutions. In addition, we rely on consultants and advisors, including scientific and clinical advisors, to assist us in formulating our research anddevelopment and commercialization strategy. Our consultants and advisors may be employed by employers other than us and may havecommitments under consulting or advisory contracts with other entities that may limit their availability to us.We expect to expand our operations, and may encounter difficulties in managing our growth, which could disrupt our business.We expect to expand the scope of our operations, particularly in the areas of drug development, regulatory affairs and sales and marketing. Tomanage our anticipated future growth, we must continue to implement and improve our managerial, operational and financial systems, expand ourfacilities and continue to recruit and train additional qualified personnel. We may not be able to effectively manage the expected expansion of ouroperations or recruit and train additional qualified personnel. Moreover, the expected expansion of our operations may lead to significant costs andmay divert our management and business development resources. Any inability to manage growth could delay the execution of our business plansor disrupt our operations.We may engage in acquisitions that could disrupt our business, cause dilution to our stockholders or reduce our financial resources.In the future, we may enter into transactions to acquire other businesses, products or technologies and our ability to do so successfully isunproven. If we do identify suitable candidates, we may not be able to make such acquisitions on favorable terms, or at all. Any acquisitions wemake may fail to strengthen our competitive position, and these transactions may be viewed negatively by customers or investors. We maydecide to incur debt in connection with an acquisition or issue our common stock or other equity securities to the stockholders of the acquiredcompany, which would reduce the percentage ownership of our existing stockholders. We could incur losses resulting from undiscovered liabilitiesof the acquired business that are not covered by the indemnification we may obtain from the seller. In addition, we may not be able to successfullyintegrate the acquired personnel, technologies and operations into our existing business in an effective, timely and non-disruptive manner.Acquisitions may also divert management attention from day-to-day responsibilities, increase our expenses and reduce our cash available foroperations and other uses. We cannot predict the number, timing or size of future acquisitions or the effect that any such transactions might haveon our operating results.Risks Related to Ownership of our Common StockThe price of our stock may be volatile, and you could lose all or part of your investment.The trading price of our common stock is likely to be highly volatile and could be subject to wide fluctuations in response to various factors, someof which are beyond our control, including limited trading volume. In addition to the factors discussed in this “Risk Factors” section and elsewherein this report, these factors include: ·the commencement, timing, enrollment or results of the current and planned clinical trials of our product candidates or any future clinicaltrials we may conduct, or changes in the development status of our product candidates; ·any delay in our regulatory filings for our product candidates and any adverse development or perceived adverse development withrespect to the applicable regulatory authority’s review of such filings, including without limitation the FDA’s issuance of a “refusal to file”letter or a request for additional information; ·adverse results or delays in clinical trials; ·our decision to initiate a clinical trial, not to initiate a clinical trial or to terminate an existing clinical trial; ·adverse regulatory decisions, including failure to receive regulatory approval of our product candidates;48CIDARA THERAPEUTICS, INC. ·changes in laws or regulations applicable to our products, including but not limited to clinical trial requirements for approvals; ·adverse developments concerning our manufacturers; ·our inability to obtain adequate product supply for any approved product or inability to do so at acceptable prices; ·our inability to establish collaborations if needed; ·our failure to commercialize our product candidates; ·additions or departures of key scientific or management personnel; ·unanticipated serious safety concerns related to the use of our product candidates; ·introduction of new products or services offered by us or our competitors; ·announcements of significant acquisitions, strategic partnerships, joint ventures or capital commitments by us or our competitors; ·our ability to effectively manage our growth; ·the size and growth of our initial fungal infection target markets; ·our ability to successfully enter new markets or develop additional product candidates; ·actual or anticipated variations in quarterly operating results; ·our cash position and our ability to raise additional capital and the terms on which we raise it; ·our failure to meet the estimates and projections of the investment community or that we may otherwise provide to the public; ·publication of research reports or other media coverage about us or our industry, or immunotherapy in particular, or positive or negativerecommendations or withdrawal of research coverage by securities analysts; ·changes in the market valuations of similar companies; ·overall performance of the equity markets; ·sales of our common stock by us or our stockholders in the future; ·trading volume of our common stock; ·changes in accounting practices; ·ineffectiveness of our internal controls; ·disputes or other developments relating to proprietary rights, including patent rights, litigation matters and our ability to obtain patentprotection for our technologies; ·significant lawsuits, including patent or stockholder litigation; ·general political and economic conditions; and ·other events or factors, many of which are beyond our control.In addition, the stock market in general, and The NASDAQ Global Market and pharmaceutical companies in particular, have experienced extremeprice and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies. Broad marketand industry factors may negatively affect the market price of our common stock, regardless of our actual operating performance. You may notrealize any return on your investment in us and may lose some or all of your investment. In the past, securities class action litigation has oftenbeen instituted against companies following periods of volatility in the market price of a company’s securities. This type of litigation, if instituted,could result in substantial costs and a diversion of management’s attention and resources, which would harm our business, operating results orfinancial condition.49CIDARA THERAPEUTICS, INC. We do not intend to pay dividends on our common stock so any returns will be limited to the value of our stock.We currently anticipate that we will retain future earnings for the development, operation and expansion of our business and do not anticipatedeclaring or paying any cash dividends for the foreseeable future. Any return to stockholders will therefore be limited to the appreciation of theirstock.Our principal stockholders and management own a significant percentage of our stock and are able to exert significant control overmatters subject to stockholder approval.Our executive officers, directors, and 5% stockholders and their affiliates currently beneficially own a significant percentage of our outstandingvoting stock. These stockholders have the ability to influence us through this ownership position. These stockholders may be able to determine allmatters requiring stockholder approval. For example, these stockholders may be able to control elections of directors, amendments of ourorganizational documents, or approval of any merger, sale of assets, or other major corporate transaction. This may prevent or discourageunsolicited acquisition proposals or offers for our common stock that you may feel are in your best interest as one of our stockholders.We are an emerging growth company, and we cannot be certain if the reduced reporting requirements applicable to emerging growthcompanies will make our common stock less attractive to investors.We are an emerging growth company, as defined in the Jumpstart Our Business Startups Act, or the JOBS Act, enacted in April 2012. For as longas we continue to be an emerging growth company, we may take advantage of exemptions from various reporting requirements that are applicableto other public companies that are not emerging growth companies, including not being required to comply with the auditor attestation requirementsof Section 404 of the Sarbanes-Oxley Act of 2002, as amended, or the Sarbanes-Oxley Act, reduced disclosure obligations regarding executivecompensation in our periodic reports and proxy statements and exemptions from the requirements of holding nonbinding advisory votes onexecutive compensation and stockholder approval of any golden parachute payments not previously approved. We could be an emerging growthcompany through 2020, although circumstances could cause us to lose that status earlier. We will remain an emerging growth company until theearlier of (1) (a) December 31, 2020, (b) the last day of the fiscal year in which we have total annual gross revenue of at least $1 billion, (c) the lastday of the fiscal year in which we are deemed to be a large accelerated filer, which requires the market value of our common stock that is held bynon-affiliates to exceed $700 million as of the prior June 30th, and (d) the date on which we have issued more than $1 billion in non-convertibledebt during the prior three-year period.Even after we no longer qualify as an emerging growth company, we may still qualify as a “smaller reporting company” which would allow us totake advantage of many of the same exemptions from disclosure requirements including not being required to comply with the auditor attestationrequirements of Section 404 of the Sarbanes-Oxley Act and reduced disclosure obligations regarding executive compensation in our periodicreports and proxy statements. We cannot predict if investors will find our common stock less attractive because we may rely on theseexemptions. If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stockand our stock price may be more volatile.Under the JOBS Act, emerging growth companies can also delay adopting new or revised accounting standards until such time as those standardsapply to private companies. We have irrevocably elected not to avail ourselves of this exemption from new or revised accounting standards and,therefore, will be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies. Asa result, changes in rules of U.S. generally accepted accounting principles or their interpretation, the adoption of new guidance or the application ofexisting guidance to changes in our business could significantly affect our financial position and results of operations.We will incur significant increased costs as a result of operating as a public company, and our management will be required to devotesubstantial time to new compliance initiatives.As a public company, we will incur significant legal, accounting and other expenses that we did not incur as a private company. We will be subjectto the reporting requirements of the Securities Exchange Act of 1934, which require, among other things, that we file with the Securities andExchange Commission, or the SEC, annual, quarterly and current reports with respect to our business and financial condition. In addition, theSarbanes-Oxley50CIDARA THERAPEUTICS, INC. Act, as well as rules subsequently adopted by the SEC and The NASDAQ Global Market to implement provisions of the Sarbanes-Oxley Act,impose significant requirements on public companies, including requiring establishment and maintenance of effective disclosure and financialcontrols and changes in corporate governance practices. Further, in July 2010, the Dodd-Frank Wall Street Reform and Consumer Protection Act,or the Dodd-Frank Act, was enacted. There are significant corporate governance and executive compensation related provisions in the Dodd-FrankAct that require the SEC to adopt additional rules and regulations in these areas such as “say on pay” and proxy access. Recent legislationpermits emerging growth companies to implement many of these requirements over a longer period and up to five years from the pricing of ourinitial public offering. We intend to take advantage of this new legislation but cannot guarantee that we will not be required to implement theserequirements sooner than budgeted or planned and thereby incur unexpected expenses. Stockholder activism, the current political environmentand the current high level of government intervention and regulatory reform may lead to substantial new regulations and disclosure obligations,which may lead to additional compliance costs and impact the manner in which we operate our business in ways we cannot currently anticipate.We expect the rules and regulations applicable to public companies to substantially increase our legal and financial compliance costs and to makesome activities more time-consuming and costly. If these requirements divert the attention of our management and personnel from other businessconcerns, they could have a material adverse effect on our business, financial condition and results of operations. The increased costs willdecrease our net income or increase our net loss, and may require us to reduce costs in other areas of our business or increase the prices of ourproducts or services. For example, we expect these rules and regulations to make it more difficult and more expensive for us to obtain director andofficer liability insurance and we may be required to incur substantial costs to maintain the same or similar coverage. We cannot predict orestimate the amount or timing of additional costs we may incur to respond to these requirements. The impact of these requirements could alsomake it more difficult for us to attract and retain qualified persons to serve on our board of directors, our board committees or as executiveofficers.Sales of a substantial number of shares of our common stock by our existing stockholders in the public market could cause our stockprice to fall.If our existing stockholders sell, or indicate an intention to sell, substantial amounts of our common stock in the public market, the trading price ofour common stock could decline. We have 13,822,747 shares of common stock outstanding as of February 29, 2016. We are unable to predictthe effect that sales may have on the prevailing market price of our common stock.Sales of our common stock by current stockholders may make it more difficult for us to sell equity or equity-related securities in the future at atime and price that we deem reasonable or appropriate, and make it more difficult for you to sell shares of our common stock. In addition, sharesof common stock that are either outstanding options or reserved for future issuance under our employee benefit plans will become eligible for salein the public market to the extent permitted by the provision of various vesting schedules and Rule 144 and Rule 701 under the Securities Act. Ifthese additional shares of common stock are sold, or if it is perceived that they will be sold, in the public market, the trading price of our commonstock could decline.Certain holders of our securities are entitled to rights with respect to the registration of their shares under the Securities Act. Registration of theseshares under the Securities Act would result in the shares becoming freely tradable without restriction under the Securities Act, except for sharesheld by affiliates, as defined in Rule 144 under the Securities Act. Any sales of securities by these stockholders could have a material adverseeffect on the trading price of our common stock.Future sales and issuances of our common stock or rights to purchase common stock, including pursuant to our equity incentive plans,could result in additional dilution of the percentage ownership of our stockholders and could cause our stock price to fall.We expect that significant additional capital may be needed in the future to continue our planned operations, including conducting clinical trials,commercialization efforts, expanded research and development activities and costs associated with operating as a public company. To raisecapital, we may sell common stock, convertible securities or other equity securities in one or more transactions at prices and in a manner wedetermine from time to time. If we sell common stock, convertible securities or other equity securities, investors may be materially51CIDARA THERAPEUTICS, INC. diluted by subsequent sales. Such sales may also result in material dilution to our existing stockholders, and new investors could gain rights,preferences and privileges senior to our existing stockholders.Pursuant to the 2015 Plan, our management is authorized to grant stock options to our employees, directors and consultants. The number ofshares of our common stock reserved for issuance under the 2015 Plan will automatically increase on January 1 of each year through andincluding January 1, 2025, by 4% of the total number of shares of our capital stock outstanding on December 31 of the preceding calendar year, ora lesser number of shares determined by our board of directors. Additionally, the number of shares of our common stock reserved for issuanceunder the 2015 ESPP will automatically increase on January 1 of each year through and including January 1, 2025, by the lesser of 1% of the totalnumber of shares of our capital stock outstanding on December 31 of the preceding calendar year, or 490,336 shares. Unless our board ofdirectors elects not to increase the number of shares available for future grant each year under the 2015 Plan and 2015 ESPP, our stockholdersmay experience additional dilution, which could cause our stock price to fall.We have broad discretion in the use of working capital and may not use it effectively.Our management will have broad discretion in the application of the working capital. Because of the number and variability of factors that willdetermine our use of our working capital, its ultimate use may vary substantially from its currently intended use. Our management might not applyour working capital in ways that ultimately increase the value of your investment. We expect to use our working capital to fund the clinicaldevelopment of CD101 IV and CD101 topical, the preclinical development and early clinical trials for our current Cloudbreak developmentcandidates, expansion of our Cloudbreak immunotherapy platform and working capital, including general operating expenses. The failure by ourmanagement to apply this working capital effectively could harm our business. Pending its use, we may invest our working capital in short-term,investment-grade, interest-bearing securities. These investments may not yield a favorable return to our stockholders. If we do not invest or applyour working capital in ways that enhance stockholder value, we may fail to achieve expected financial results, which could cause our stock priceto decline.Anti-takeover provisions under our charter documents and Delaware law could delay or prevent a change of control which could limit themarket price of our common stock and may prevent or frustrate attempts by our stockholders to replace or remove our currentmanagement.Our amended and restated certificate of incorporation and amended and restated bylaws contain provisions that could delay or prevent a change ofcontrol of our company or changes in our board of directors that our stockholders might consider favorable. Some of these provisions include: ·a board of directors divided into three classes serving staggered three-year terms, such that not all members of the board will be electedat one time; ·a prohibition on stockholder action through written consent, which requires that all stockholder actions be taken at a meeting of ourstockholders; ·a requirement that special meetings of stockholders be called only by the chairman of the board of directors, the chief executive officer,or by a majority of the total number of authorized directors; ·advance notice requirements for stockholder proposals and nominations for election to our board of directors; ·a requirement that no member of our board of directors may be removed from office by our stockholders except for cause and, inaddition to any other vote required by law, upon the approval of not less than two-thirds of all outstanding shares of our voting stock thenentitled to vote in the election of directors; ·a requirement of approval of not less than two-thirds of all outstanding shares of our voting stock to amend any bylaws by stockholderaction or to amend specific provisions of our certificate of incorporation; and ·the authority of the board of directors to issue preferred stock on terms determined by the board of directors without stockholderapproval and which preferred stock may include rights superior to the rights of the holders of common stock.52CIDARA THERAPEUTICS, INC. In addition, because we are incorporated in Delaware, we are governed by the provisions of Section 203 of the Delaware General Corporate Law,which may prohibit certain business combinations with stockholders owning 15% or more of our outstanding voting stock. These anti-takeoverprovisions and other provisions in our amended and restated certificate of incorporation and amended and restated bylaws could make it moredifficult for stockholders or potential acquirers to obtain control of our board of directors or initiate actions that are opposed by the then-currentboard of directors and could also delay or impede a merger, tender offer or proxy contest involving our company. These provisions could alsodiscourage proxy contests and make it more difficult for you and other stockholders to elect directors of your choosing or cause us to take othercorporate actions you desire. Any delay or prevention of a change of control transaction or changes in our board of directors could cause themarket price of our common stock to decline.Because we have an even number of members of our board of directors, deadlocks may occur in our board of directors’ decision-making process, which may delay or prevent critical decisions from being made.Since we currently have an even number of directors, deadlocks may occur when such directors disagree on a particular decision or course ofaction. Our amended and restated certificate of incorporation and amended and restated bylaws do not contain any mechanisms for resolvingpotential deadlocks. While our directors are under a duty to act in the best interest of our company, any deadlocks may impede the furtherdevelopment of our business in that such deadlocks may delay or prevent critical decisions regarding our development.Our amended and restated bylaws provide that the Court of Chancery of the State of Delaware will be the exclusive forum forsubstantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicialforum for disputes with us or our directors, officers or employees.Our amended and restated bylaws provide that the Court of Chancery of the State of Delaware is the exclusive forum for any derivative action orproceeding brought on our behalf; any action asserting a breach of fiduciary duty; any action asserting a claim against us arising pursuant to theDelaware General Corporation Law, our certificate of incorporation or our bylaws; or any action asserting a claim against us that is governed by theinternal affairs doctrine. The choice of forum provision may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable fordisputes with us or our directors, officers or other employees, which may discourage such lawsuits against us and our directors, officers and otheremployees. Alternatively, if a court were to find the choice of forum provision contained in our amended and restated bylaws to be inapplicable orunenforceable in an action, we may incur additional costs associated with resolving such action in other jurisdictions, which could adversely affectour business and financial condition.If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our stockprice and trading volume could decline.The trading market for our common stock will depend in part on the research and reports that securities or industry analysts publish about us orour business. If one or more of the analysts who covers us downgrades our stock or publishes inaccurate or unfavorable research about ourbusiness, our stock price may decline. If one or more of these analysts ceases coverage of our company or fails to publish reports on us regularly,demand for our stock could decrease, which might cause our stock price and trading volume to decline.Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited.Under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, if a corporation undergoes an “ownership change” (generallydefined as a greater than 50% change (by value) in its equity ownership over a three-year period), the corporation’s ability to use its pre-change netoperating loss carryforwards and other pre-change tax attributes to offset its post-change income may be limited. As a result of our initial publicoffering, our most recent private placements and other transactions that have occurred since our inception in 2012, we may or may not haveexperienced an “ownership change.” We may also experience ownership changes in the future as a result of subsequent shifts in our stockownership. As of December 31, 2015, we had U.S. net operating loss carryforwards of approximately $39.3 million, which begin to expire in 2032,which could be limited if we experience an “ownership change.” 53CIDARA THERAPEUTICS, INC. Item 1B. Unresolved Staff Comments.Not applicable. Item 2. Properties.We lease a 29,638 square foot facility in San Diego, California for administrative, research and development activities. Our lease currently expiresin December 2018, subject to our option to renew for up to two additional two-year terms. We believe that our facility is sufficient to meet ourneeds and that suitable additional space will be available as and when needed. Item 3. Legal Proceedings.None. Item 4. Mine Safety Disclosures.Not applicable. 54CIDARA THERAPEUTICS, INC. PART IIItem 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.Market InformationOur common stock is traded on The NASDAQ Global Market under the symbol “CDTX.” The following table sets forth the high and low salesprices per share of our common stock as reported on The NASDAQ Global Market for the periods indicated. High Low Second quarter ended June 30, 2015 (beginning April 15, 2015)$19.13 $13.34 Third quarter ended September 30, 2015$15.48 $11.23 Fourth quarter ended December 31, 2015$18.07 $12.03 Holders of RecordAs of February 29, 2016, there were approximately 29 holders of record for our common stock.Dividend PolicyWe do not anticipate declaring or paying, in the foreseeable future, any cash dividends on our capital stock. We currently intend to retain allavailable funds and any future earnings to support our operations and finance the growth and development of our business. Any futuredetermination related to our dividend policy will be made at the discretion of our board of directors and will depend upon, among other factors, ourresults of operations, financial condition, capital requirements, contractual restrictions, business prospects and other factors our board of directorsmay deem relevant.Securities Authorized for Issuance Under Equity Compensation PlansInformation about our equity compensation plans is incorporated herein by reference to Item 12 of Part III of this Annual Report.55CIDARA THERAPEUTICS, INC. Performance GraphThe following graph shows a comparison from April 15, 2015 (the date our common stock commenced trading on The NASDAQ Global Market)through December 31, 2015 of the cumulative total return for our common stock, the NASDAQ Biotechnology Index (NBI) and the NASDAQComposite Index (CCMP). The graph assumes an initial investment of $100 on April 15, 2015. The comparisons in the graph are not intended toforecast or be indicative of possible future performance of our common stock. Use of ProceedsOn April 14, 2015, our Registration Statements on Form S-1 (file Nos. 333-202740 and 333-203434) were declared effective by the SEC for ourinitial public offering of common stock. We started trading on The NASDAQ Global Market on April 15, 2015. We issued 4,800,000 shares ofcommon stock at an offering price of $16.00 per share for proceeds of approximately $69.3 million, net of underwriting discounts, commissionsand offering expenses. The offering was completed on April 20, 2015.The net proceeds from this offering have been invested in short- and intermediate-term, interest-bearing obligations, investment-grade instruments,certificates of deposit or direct or guaranteed obligations of the U.S. government. As of December 31, 2015, we did not use any of the netproceeds from the offering. 56CIDARA THERAPEUTICS, INC. Item 6. Selected Financial Data.The selected financial data set forth below is derived from our audited financial statements and may not be indicative of future operating results.The following selected financial data should be read in conjunction with the financial statements and notes thereto and Item 7, “Management’sDiscussion and Analysis of Financial Condition and Results of Operations” included elsewhere in this Annual Report. The selected financial data inthis section are not intended to replace our financial statements and the related notes. Our historical results are not necessarily indicative of ourfuture results. Amounts are in thousands, except share and per share data.Statement of Operations Data Year ended December 31, (In thousands, except share and per share data)2015 2014 2013 Operating expenses: Research and development$23,475 $6,710 $810 Cost of in-process research and development acquired - 1,607 - General and administrative 8,838 3,306 272 Total operating expenses 32,313 11,623 1,082 Loss from operations (32,313) (11,623) (1,082)Other income (expense): Interest income (expense), net 120 (88) (95)Change in fair value of convertible notes payable - (183) (167)Total other income (expense) 120 (271) (262)Net loss$(32,193) $(11,894) $(1,344)Net loss per common share, basic and diluted$(3.25) $(14.51) $(4.15)Weighted average shares outstanding used to compute net loss per share, basic and diluted 9,920,382 819,868 323,689 Balance Sheet Data December 31, 2015 2014 2013 Cash, cash equivalents, and short-term investments$107,514 $22,796 $185 Working capital 102,244 19,800 82 Total assets 109,974 24,350 201 Convertible preferred stock - 32,548 - Accumulated deficit (45,497) (13,304) (1,410)Total stockholders' equity (deficit) 103,912 (11,445) (1,398) 57CIDARA THERAPEUTICS, INC. Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.You should read the following discussion and analysis together with “Item 6. Selected Financial Data” and our financial statements and relatednotes included elsewhere in this Annual Report.Forward-Looking StatementsThe following discussion contains forward-looking statements that involve risks and uncertainties. These forward-looking statements involve risksand uncertainties that could cause our actual results to differ materially from those in the forward-looking statements, including, without limitation,the risks set forth in Part II, Item 1A, “Risk Factors” in this Annual Report. See “Special Note Regarding Forward-Looking Statements.”OverviewWe are a biotechnology company focused on the discovery, development and commercialization of novel anti-infectives for the treatment ofdiseases that are inadequately addressed by current standard of care therapies. We are developing a balanced pipeline of product anddevelopment candidates, with an initial focus on serious fungal infections. Our lead clinical candidates are echinocandins, a proven class ofantifungals. Our initial product portfolio comprises two formulations of our novel echinocandin, CD101. CD101 IV is a long-acting therapy for thetreatment and prevention of serious, invasive fungal infections. CD101 topical, our second product candidate, is being developed for the treatmentof vulvovaginal candidiasis (VVC) and recurrent VVC (RVVC), a prevalent mucosal infection. In addition, we have developed a proprietaryimmunotherapy technology platform, CloudbreakTM, which we use to create compounds designed to direct a patient’s immune cells to attack andeliminate pathogens that cause infectious disease. We are evaluating Cloudbreak candidates for the treatment of invasive fungal infectionsincluding aspergillosis, an infection caused by the fungal pathogen, Aspergillus. We are also evaluating additional opportunities to expand ourCloudbreak immunotherapy platform and have the potential to transform the treatment of infectious disease caused by a variety of fungal, bacterialand viral pathogens.CD101 IVIn November 2015, we obtained data from our single ascending dose (SAD) study. This was a Phase 1, randomized, double-blind, placebo-controlled, dose-escalation study to determine the safety, tolerability, and pharmacokinetics of single intravenous doses of CD101 in healthysubjects. Results demonstrated that CD101 IV was well tolerated in all dose cohorts after single doses of 50 mg, 100 mg, 200 mg, and 400 mg.CD101 IV exhibited a pharmacokinetic profile consistent with preclinical data and supportive of once-weekly dosing.In January 2016, we obtained data from our multiple ascending dose (MAD) Phase 1 study. This was a Phase 1, randomized, double-blind,placebo-controlled, dose-escalation study to determine the safety, tolerability, and pharmacokinetics of multiple intravenous doses of CD101 inhealthy subjects. Results demonstrated that CD101 IV was well tolerated in all dose cohorts after multiple doses of 100 mg, 200 mg, and 400 mg.CD101 IV exhibited a pharmacokinetic profile consistent with preclinical data and supportive of once-weekly dosing.In February 2016, we received Orphan Drug Designation for CD101IV in Candidemia and Invasive Candidasis. This designation provides useligibility for seven years of market exclusivity in the United States upon FDA approval, a waiver from payment of User Fees, an exemption fromperforming clinical studies in pediatric patients, and tax credits for the cost of clinical research.We plan to initiate a Phase 2 clinical trial in candidemia in the first half of 2016. We plan to enroll approximately 90 patients with Candidabloodstream infections and expect results from this trial in the second half of 2017.CD101 TopicalWe are planning to file our Initial New Drug, or IND, application for CD101 topical during the first half of 2016. Based on discussions with the U.S.Food and Drug Administration, or FDA, we are planning to initiate a Phase 2 multi-site clinical trial in mid-2016 to investigate the safety,tolerability, and initial efficacy of CD101 topical in women with VVC. We expect results from this trial in mid-2017.58CIDARA THERAPEUTICS, INC. Cloudbreak Immunotherapy PlatformWe are expanding our Cloudbreak immunotherapy platform to include the development of both small and large molecule candidates. Thisexpansion will enable us to select development candidates that effectively engage the immune system and target the site of infection. We believethat our Cloudbreak immunotherapy platform has broad potential applications across a wide spectrum of infectious diseases, including fungal,bacterial and viral infections. We plan to select a lead Cloudbreak development candidate in 2016.FINANCIAL OPERATIONS OVERVIEWRevenuesTo date, we have not generated any revenues. In the future, we may generate revenue from a combination of license fees and other upfrontpayments, research and development payments, milestone payments, product sales, government and other third-party funding, and royalties inconnection with strategic alliances. We expect that any revenue we generate will fluctuate from quarter-to-quarter as a result of the timing of ourachievement of preclinical, clinical, regulatory and commercialization milestones, if at all, the timing and amount of payments relating to suchmilestones and the extent to which any of our products are approved and successfully commercialized. If we are unable to fund our developmentcosts, or we are unable to develop product candidates in a timely manner or obtain regulatory approval for them, our ability to generate futurerevenues and our results of operations and financial position would be adversely affected.Research and development expensesTo date, our research and development expenses have related primarily to preclinical development of our CD101 product candidates and ourCloudbreak immunotherapy technology platform, as well as clinical development of CD101 IV. Research and development expenses consist ofwages, benefits and stock-based compensation for research and development employees, as well as the cost of scientific consultants, facilitiesand overhead expenses, laboratory supplies, manufacturing expenses, and preclinical and clinical trial costs. The Company accrues clinical trialexpenses based on work performed which relies on estimates of total costs incurred based on patient enrollment, completion of studies and otherevents.Research and development costs are expensed as incurred and costs incurred by third parties are expensed as the contracted work is performed.We accrue for costs incurred as the services are being provided by monitoring the status of the study or project and the invoices received from ourexternal service providers. We adjust our accruals as actual costs become known.Research and development activities are central to our business model. Product candidates in later stages of clinical development generally havehigher development costs than those in earlier stages of development, primarily due to the increased size and duration of later-stage clinical trials.We expect our research and development expenses to increase over the next several years as we continue to conduct preclinical and clinicalstudies, expand our research and development pipeline and progress our product candidates through clinical trials. However, it is difficult todetermine with certainty the duration, costs and timing to complete our current or future preclinical programs and clinical trials of our productcandidates.The duration, costs and timing of clinical trials and development of our product candidates will depend on a variety of factors that include, but arenot limited to, the following: ·per patient trial costs; ·the number of patients that participate in the trials; ·the number of sites included in the trials; ·the countries in which the trials are conducted; ·the length of time required to enroll eligible patients; ·the number of doses that patients receive; ·the drop-out or discontinuation rates of patients; ·potential additional safety monitoring or other studies requested by regulatory agencies;59CIDARA THERAPEUTICS, INC. ·the duration of patient follow-up; ·the phase of development of the product candidate; and ·the efficacy and safety profile of the product candidates.Research and development expenses by major program or category were as follows (in thousands): Year ended December 31, 2015 2014 2013 CD101 IV$7,753 $2,170 $- CD101 topical 3,830 233 - Cloudbreak immunotherapy platform 2,249 1,374 810 Cost of in-process research and development acquired - 1,607 - Personnel costs 6,752 1,305 - Other research and development expenses 2,891 1,628 - Total research and development expenses$23,475 $8,317 $810 We typically deploy our employees, consultants and infrastructure resources across our programs. Thus, some of our research and developmentexpenses are not attributable to an individual program but are included in other research and development expenses as shown above.In addition, the probability of success for each product candidate will depend on numerous factors, including competition, manufacturing capabilityand commercial viability. We will determine which programs to pursue and how much to fund each program in response to the scientific andclinical success of each product candidate, as well as an assessment of each product candidate’s commercial potential.General and administrative expensesGeneral and administrative expenses consist primarily of salaries and related benefits, including stock-based compensation, related to ourexecutive, finance, legal, business development, commercial planning, and support functions. Other general and administrative expenses includeallocated facility-related costs not otherwise included in research and development expenses, travel expenses and professional fees for auditing,tax and legal services. We expect that general and administrative expenses will increase in the future as we expand our operating activities andincur additional costs associated with operating as a publicly traded company. These increases will likely include legal fees, accounting fees,directors’ and officers’ liability insurance premiums and fees associated with investor relations.Other income (expense), netOther income (expense) consists primarily of interest income and expense, and various income or expense items of a non-recurring nature. Weearn interest income from interest-bearing accounts and money market funds for cash and cash equivalents and marketable securities and for ourshort-term investments. Interest expense has historically represented interest payable related to convertible notes payable and the amortization ofdebt issuance costs. We recorded periodic gains and losses from changes in fair value of convertible notes payable until their conversion intopreferred stock in May 2014.CRITICAL ACCOUNTING POLICIES AND ESTIMATESThe preparation of our unaudited financial statements requires us to make estimates and assumptions that affect the reported amounts of assetsand liabilities, disclosure of contingent assets and liabilities, and the revenues and expenses incurred during the reported periods. We believe thatthe estimates, assumptions and judgments involved in the accounting policies described in Management’s Discussion and Analysis of FinancialCondition and Results of Operations under Note 1 to our financial statements contained in our Annual Report on Form 10-K, as amended, have thegreatest potential impact on our financial statements, so we consider them to be our critical accounting policies and estimates. There were nomaterial changes to our critical accounting policies and estimates during the year ended December 31, 2015.60CIDARA THERAPEUTICS, INC. Clinical and Preclinical Trial AccrualsWe make estimates of our accrued expenses as of each balance sheet date in our financial statements based on the facts and circumstancesknown to us at that time. Our accrued expenses for pre-clinical studies and clinical trials are based on estimates of costs incurred and fees thatmay be associated with services provided by clinical trial investigational sites, clinical research organizations (“CROs”) and for other clinical trial-related activities. Payments under certain contracts with such parties depend on factors such as successful enrollment of patients, site initiationand the completion of clinical trial milestones. In accruing for these services, we estimate the time period over which services will be performedand the level of effort to be expended in each period. If possible, we obtain information regarding unbilled services directly from these serviceproviders. However, we may be required to estimate these services based on other information available to us. If we underestimate oroverestimate the activities or fees associated with a study or service at a given point in time, adjustments to research and development expensesmay be necessary in future periods. Historically, our estimated accrued liabilities have approximated actual expense incurred. Subsequentchanges in estimates may result in a material change in our accruals.Stock-based compensationThe Company accounts for stock-based compensation expense related to employee stock options, restricted stock grants, and employee stockpurchase plan rights by estimating the fair value on the date of grant. For awards subject to time-based vesting conditions, stock-basedcompensation expense is recognized ratably over the requisite service period of the awards, net of estimated forfeitures. The Company accountsfor stock options granted to non-employees using the fair value approach. These option grants are subject to periodic revaluation over their vestingterms.The Company estimates the fair value of stock option awards to employees and non-employees using the Black-Scholes option pricing model,which requires the input of highly subjective assumptions, including (a) the risk-free interest rate, (b) the expected volatility of our stock, (c) theexpected term of the award, and (d) the expected dividend yield. Due to the lack of an adequate history of a public market for the trading of ourcommon stock and a lack of adequate company-specific historical and implied volatility data, we have based our estimate of expected volatility onthe historical volatility of a group of similar companies that are publicly traded. For these analyses, we have selected companies with comparablecharacteristics to ours, including enterprise value, risk profiles, position within the industry, and with historical share price information sufficient tomeet the expected life of the stock-based awards. We compute the historical volatility data using the daily close prices for the selectedcompanies’ shares during the equivalent period of the calculated expected term of our stock-based awards. We will continue to apply this processuntil a sufficient amount of historical information regarding the volatility of our common stock price becomes available. We have estimated theexpected life of our employee stock options using the “simplified” method, whereby the expected life equals the average of the vesting term andthe original contractual term of the option. The risk-free interest rates for periods within the expected life of the option are based on the yields ofzero-coupon U.S. treasury securities. See note 8 of the Notes to the Financial Statements for additional information.RESULTS OF OPERATIONSComparison of the years ended December 31, 2015 and 2014The following table summarizes our results of operations for the years ended December 31, 2015 and 2014 (in thousands): Year ended December 31, 2015 2014 Change Research and development$23,475 $6,710 16,765 Cost of in-process research and development acquired - 1,607 (1,607)General and administrative 8,838 3,306 5,532 Other income (expense), net 120 (271) 39161CIDARA THERAPEUTICS, INC. Research and development expensesResearch and development expenses were $23.5 million for the year ended December 31, 2015 compared to $6.7 million for the year endedDecember 31, 2014. Research and development activities have expanded compared to the same period in the prior year. We acquired theintellectual property for CD101 in May 2014 and commenced development activities for two product candidates, CD101 IV and CD101 topical. Weconducted two Phase 1 clinical trials for CD101 IV in 2015 and continued preclinical development of CD101 topical in preparation for an INDfiling. In addition, we expanded early-stage research and preclinical development for our Cloudbreak program. We began to hire employees in thethird quarter of 2014 and headcount has increased to support the research and development activities associated with our programs.In-process research and developmentIn May 2014, we entered into an asset purchase agreement with Seachaid Pharmaceuticals, or Seachaid, whereby we purchased the intellectualproperty for CD101. In exchange for the intellectual property, we issued 703,092 shares of common stock to the shareholders of Seachaid with afair value of $1.6 million, as consideration for the assets acquired.General and administrative expensesGeneral and administrative expenses were $8.8 million for the year ended December 31, 2015 compared to $3.3 million for the year endedDecember 31, 2014. The increase in general and administrative expenses was primarily related to the expansion of our operating activities whichrequired additional personnel. In addition, we have incurred increased costs to operate as a publicly traded company, including insurance, auditand tax fees, and investor and public relations expenses.Other Income (Expense)Other income, net, for the year ended December 31, 2015 relates primarily to income generated from cash held in interest-bearinginvestments. Other expense for the year ended December 31, 2014 related primarily to the change in fair value of convertible notes payable whichwere marked to their estimated fair values until their conversion into Series A convertible preferred stock in May 2014. In addition, the convertiblenotes payable accrued interest at 8% while they were outstanding.Comparison of the year ended December 31, 2014 and 2013The following table summarizes our results of operations for the years ended December 31, 2014 and 2013 (in thousands): Year ended December 31, 2014 2013 Change Research and development$6,710 $810 5,900 Cost of in-process research and development acquired$1,607 - 1,607 General and administrative$3,306 272 3,034 Other expense, net$(271) (262) (9) Research and development expensesResearch and development expenses were $6.7 million for the year ended December 31, 2014 compared to $0.8 million for the year endedDecember 31, 2013. Research and development activities have expanded compared to the same period in the prior year. We acquired theintellectual property for CD101 in May 2014 and commenced development activities for two product candidates, CD101 IV and CD101 topical. Inaddition, we expanded early-stage research and preclinical development for our Cloudbreak program. We began to hire employees in the thirdquarter of 2014 and headcount increased to support the research and development activities associated with our programs. We had no researchand development employees during 2013.62CIDARA THERAPEUTICS, INC. In-process research and developmentIn May 2014, we entered into an asset purchase agreement with Seachaid Pharmaceuticals, or Seachaid, whereby we purchased the intellectualproperty for CD101. In exchange for the intellectual property, we issued 703,092 shares of common stock to the shareholders of Seachaid, with afair value of $1.6 million, as consideration for the assets acquired.General and administrative expensesGeneral and administrative expenses were $3.3 million for the year ended December 31, 2014 compared to $0.3 million for the year endedDecember 31, 2013. We began hiring our current workforce and transitioned from a company with no employees or facilities to one staffed withemployees and a physical presence in San Diego, California during the second half of 2014.Other Income (Expense)Other expense during the years ended December 31, 2014 and 2013 related primarily to the change in fair value of convertible notes payable whichwere marked to their estimated fair values until their conversion into Series A convertible preferred stock in May 2014. In addition, the convertiblenotes payable accrued interest at 8% while they were outstanding.LIQUIDITY AND CAPITAL RESOURCESSince our inception, we have received $151.0 million in gross proceeds to fund our operations, primarily through private placements of convertiblepreferred stock, convertible notes, and our initial public offering.As of December 31, 2015, we had $62.6 million in cash and cash equivalents and $45.0 million in short-term investments. The following tableshows a summary of our cash flows for the years ended December 31, 2015, 2014 and 2013 (in thousands): Year ended December 31, 2015 2014 2013 Net cash provided by (used in): Operating activities$(25,959) $(7,710) $(1,048)Investing activities (46,088) (991) - Financing activities 111,813 31,312 1,232 Net increase in cash and cash equivalents$39,766 $22,611 $184 Operating activitiesNet cash used in operating activities was $26.0 million for the year ended December 31, 2015 compared to $7.7 million and $1.0 million for theyears ended December 31, 2014 and 2013, respectively. The increase in net cash used in operating activities was attributable to a net loss of$32.2 million for the year ended December 31, 2015 compared to net losses of $11.9 million and $1.3 million for the years ended December 31,2014 and 2013, respectively. For all periods presented, the primary use of cash was to fund increased levels of research and developmentactivities for our product candidates, which activities and uses of cash we expect to continue to increase for the foreseeable future.Investing activitiesFor the year ended December 31, 2015, net cash used in investing activities related primarily to the net of purchases and maturities of short-terminvestments of $44.9 million. We invest cash in excess of our immediate operating requirements with staggered investment duration or maturity tooptimize our return on investment while satisfying our liquidity needs. Net cash used for the purchase of property and equipment was $1.2 millionand $1.0 million for the years ended December 31, 2015 and 2014, respectively.63CIDARA THERAPEUTICS, INC. Financing activitiesNet cash provided by financing activities was $111.8 million for the year ended December 31, 2015 compared to $31.3 million and $1.2 million forthe years ended December 31, 2014 and 2013, respectively. During the year ended December 31, 2015, net proceeds from the sale of our SeriesB convertible preferred stock and our initial public offering were $41.9 million and $69.5 million, respectively. During the year ended December 31,2014, net proceeds from the sale of our Series A convertible preferred stock were $29.9 million. Finally, proceeds from issuance of convertiblenotes were $0.9 million and $1.2 million for the years ended December 31, 2014 and 2013, respectively.Operating Capital RequirementsTo continue to fund operations, we will need to raise additional capital. We may obtain additional financing in the future through the issuance of ourcommon stock, through other equity or debt financings or through collaborations or partnerships with other companies. We may not be able to raiseadditional capital on terms acceptable to us, or at all, and any failure to raise capital as and when needed could compromise our ability to executeon our business plan. Although it is difficult to predict future liquidity requirements, we believe that our existing cash and cash equivalents will besufficient to fund our operations for at least the next twelve months. However, our ability to successfully transition to profitability will be dependentupon achieving a level of product sales adequate to support our cost structure. We cannot assure you that we will ever be profitable or generatepositive cash flow from operating activities.CONTRACTUAL OBLIGATIONS AND COMMITMENTSThere have been no material changes, outside of the ordinary course of business, in our outstanding contractual obligations from those disclosedwithin “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” as contained in our final prospectus relating toour Registration Statement on Form S-1, as amended. The following is a summary of our long-term contractual obligations as of December 31, 2015 (in thousands): 2016$704 2017 725 2018 747 Total minimum lease payments$2,176In August 2015, the Company entered into an amendment to its lease agreement for office space. The lease amendment extended the term toDecember 31, 2018 and increased the space by approximately 11,000 square feet to a total of approximately 30,000 square feet. CommencingOctober 1, 2015, the base monthly rent was adjusted to approximately $58,000. The lease is subject to charges for common area maintenanceand other costs and the base rent is subject to 3% annual increases every July.Off-Balance Sheet ArrangementsAs of December 31, 2015, we did not have any off-balance sheet arrangements. Item 7A. Quantitative and Qualitative Disclosures About Market Risk.The primary objectives of our investment activities are to ensure liquidity and to preserve principal while at the same time maximizing the incomewe receive from our cash and cash equivalents without significantly increasing risk. Additionally, we established guidelines regarding approvedinvestments and maturities of investments, which are designed to maintain safety and liquidity.The market risk inherent in our financial instruments and in our financial position is the potential loss arising from adverse changes in interestrates. We generally hold our cash in checking and savings accounts and invest excess capital in money market funds, certificates of deposit,corporate debt, and commercial paper. Our primary exposure to market risk is interest rate sensitivity, which is affected by changes in the generallevel of U.S.64CIDARA THERAPEUTICS, INC. interest rates. To minimize our exposure to adverse shifts in interest rates, we invest in short-term securities and ensure that the maximumaverage maturity of our investments does not exceeded 12 months. If a 10% change in interest rates had occurred on December 31, 2015, thischange would not have had a significant impact on the fair value of our investment portfolio as of that date. 65CIDARA THERAPEUTICS, INC. Item 8. Financial Statements and Supplementary Data.Report of Independent Registered Public Accounting FirmThe Board of Directors and Stockholders of Cidara Therapeutics, Inc.We have audited the balance sheets of Cidara Therapeutics, Inc. as of December 31, 2015 and 2014, and the related statements of operations andcomprehensive loss, convertible preferred stock and stockholders’ equity (deficit), and cash flows for each of the three years in the period endedDecember 31, 2015. These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinionon these financial statements based on our audits.We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standardsrequire that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of materialmisstatement. We were not engaged to perform an audit of the Company’s internal control over financial reporting. Our audits includedconsideration of internal control over financial reporting as a basis for designing audit procedures that are appropriate in the circumstances, but notfor the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we expressno such opinion. An audit also includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements,assessing the accounting principles used and significant estimates made by management, and evaluating the overall financial statementpresentation. We believe that our audits provide a reasonable basis for our opinion.In our opinion, the financial statements referred to above present fairly, in all material respects, the financial position of Cidara Therapeutics, Inc.at December 31, 2015 and 2014, and the results of its operations and its cash flows for each of the three years in the period ended December 31,2015, in conformity with U.S. generally accepted accounting principles./s/ Ernst & Young LLPSan Diego, CaliforniaMarch 17, 2016 66CIDARA THERAPEUTICS, INC. Balance Sheets December 31,2015 December 31,2014 (In thousands, except share and per share data) ASSETS Current assets: Cash and cash equivalents$62,562 $22,796 Short-term investments 44,952 - Prepaid expenses and other current assets 704 217 Total current assets 108,218 23,013 Property and equipment, net 1,684 863 Other assets 72 474 Total assets$109,974 $24,350 LIABILITIES, CONVERTIBLE PREFERRED STOCK, AND STOCKHOLDERS' EQUITY (DEFICIT) Current liabilities: Accounts payable$3,095 $1,177 Accrued liabilities 1,415 1,622 Accrued compensation and benefits 1,464 414 Total current liabilities 5,974 3,213 Other long-term liabilities 88 34 Total liabilities 6,062 3,247 Commitments and contingencies Series A convertible preferred stock, $0.0001 par value; no shares authorized, issued andoutstanding at December 31, 2015; 127,214,000 shares authorized and 97,526,081 shares issuedand outstanding at December 31, 2014 - 32,548 Stockholders' equity (deficit): Preferred stock, $0.0001 par value; 10,000,000 shares authorized and no shares issued oroutstanding at December 31, 2015; no shares authorized, issued, or outstanding at December 31,2014. - - Common stock, $0.0001 par value; 200,000,000 and 185,000,000 shares authorized at December31, 2015 and 2014, respectively; 13,942,520 and 13,786,285 shares issued and outstanding,respectively, at December 31, 2015; 1,494,506 and 1,132,738 shares issued and outstanding,respectively, atDecember 31, 2014 1 - Additional paid-in capital 149,416 1,859 Accumulated other comprehensive loss (8) - Accumulated deficit (45,497) (13,304)Total stockholders' equity (deficit) 103,912 (11,445)Total liabilities, convertible preferred stock, and stockholders' equity (deficit)$109,974 $24,350 See accompanying notes. 67CIDARA THERAPEUTICS, INC. Statements of Operations and Comprehensive Loss Years ended December 31, (In thousands, except share and per share data)2015 2014 2013 Operating expenses: Research and development$23,475 $6,710 $810 Cost of in-process research and development acquired - 1,607 - General and administrative 8,838 3,306 272 Total operating expenses 32,313 11,623 1,082 Loss from operations (32,313) (11,623) (1,082)Other income (expense): Interest income (expense), net 120 (88) (95)Change in fair value of convertible notes payable - (183) (167)Total other income (expense) 120 (271) (262)Net loss$(32,193) $(11,894) $(1,344)Other comprehensive loss: Unrealized loss on short-term investments (8) - - Comprehensive loss$(32,201) $(11,894) $(1,344)Basic and diluted net loss per share$(3.25) $(14.51) $(4.15)Shares used to compute basic and diluted net loss per share 9,920,382 819,868 323,689 See accompanying notes. 68CIDARA THERAPEUTICS, INC. Statements of Convertible Preferred Stock and Stockholders’ Equity (Deficit) Series A ConvertiblePreferred Stock Series B ConvertiblePreferred Stock Common Stock AdditionalPaid-In Accumulated OtherComprehensive TotalStockholders' (In thousands, exceptshare data)Shares Amount Shares Amount Shares Amount Capital Deficit Income (Loss) Equity(Deficit) Balance, December 31,2012 - $- - $- 385,825 $- $1 $(66)$- $(65)Modification of foundersshares to add vestingrestrictions - - - - (118,110) - - - - - Vesting of restrictedshares - - - - 98,837 - - - - - Stock-basedcompensation - - - - - - 11 - - 11 Net loss - - - - - - - (1,344) - (1,344)Balance, December 31,2013 - - - - 366,552 - 12 (1,410) - (1,398)Issuance of Series Aconvertible preferredstock, net of issuancecosts of $159 89,360,118 29,866 - - - - - - - - Issuance of Series Aconvertible preferred stockupon conversion ofconvertible notes payable 8,165,963 2,682 - - - - - - - - Issuance of commonstock for in-processresearch and development - - - - 703,092 - 1,607 - - 1,607 Vesting of restrictedshares - - - - 61,913 - 5 - - 5 Issuance of commonstock for exercise of stockoptions - - - - 1,181 - 3 - - 3 Stock-basedcompensation - - - - - - 232 - - 232 Net loss - - - - - - - (11,894) - (11,894)Balance, December 31,2014 97,526,081 32,548 - - 1,132,738 - 1,859 (13,304) - (11,445)Issuance of Series Bconvertible preferredstock, net of issuancecosts of $99 - - 94,533,183 41,921 - - - - - - Conversion of Series Aand Series B convertiblepreferred upon initial publicoffering (97,526,081) (32,548) (94,533,183) (41,921) 7,561,380 1 74,468 - - 74,469 Public offering of commonstock, net of issuancecosts - - - - 4,800,000 - 69,271 - - 69,271 Stock-basedcompensation - - - - - - 3,033 - - 3,033 Issuance of commonstock under employeestock purchase plan - - - - 19,164 - 225 - - 225 Vesting of restrictedshares - - - - 249,465 - 499 - - 499 Issuance of commonstock for exercise of stockoptions - - - - 23,538 - 61 - - 61 Unrealized loss onmarketable securities - - - - - - - - (8) (8)Net loss - - - - - - - (32,193) - (32,193)Balance, December 31,2015 - $- - $- 13,786,285 $1 $149,416 $(45,497)$(8)$103,912 See accompanying notes. 69CIDARA THERAPEUTICS, INCNotes to Consolidated Financial Statements — Continued Statements of Cash Flows Years ended December 31, (In thousands)2015 2014 2013 Operating activities: Net loss$(32,193) $(11,894) $(1,344)Adjustments to reconcile net loss to net cash used in operating activities: Depreciation and amortization 461 179 - Stock-based compensation 3,033 232 11 Non-cash interest expense - 66 66 Amortization of discount or premium on short-term investments (42) - - Change in fair value of convertible notes payable - 183 167 Amortization of debt issue costs 22 23 29 Deferred rent 54 34 - Purchase of in-process research and development - 1,607 - Changes in operating assets and liabilities: Prepaid expenses and other current assets (487) (204) (13)Accounts payable and accrued liabilities 2,143 1,746 36 Accrued compensation 1,050 414 - Other assets - (96) - Net cash used in operating activities (25,959) (7,710) (1,048) Investing activities: Purchases of short-term investments (54,918) - - Maturities of short-term investments 10,000 - - Purchases of property and equipment (1,170) (991) - Net cash used in investing activities (46,088) (991) - Financing activities: Proceeds from issuance of Series A convertible preferred stock, net of offering costs - 29,866 - Proceeds from issuance of Series B convertible preferred stock, net of offering costs 41,921 - - Proceeds from initial public offering, net of offering costs 69,505 - - Deferred initial public offering costs - (233) - Proceeds from exercise of stock options and employee stock purchase plan 387 749 - Proceeds from issuance of convertible notes payable, net of offering costs - 930 1,232 Net cash provided by financing activities 111,813 31,312 1,232 Net increase in cash and cash equivalents 39,766 22,611 184 Cash and cash equivalents at beginning of period 22,796 185 1 Cash and cash equivalents at end of period$62,562 $22,796 $185 Non-cash investing activity: Property and equipment acquired but not yet paid$113 $51 $- Non-cash financing activities: Deferred initial public offering costs$234 $146 $- Conversion of Series A convertible preferred stock to common stock upon initial publicoffering$32,548 $- $- Conversion of Series B convertible preferred stock to common stock upon initial publicoffering$41,921 $- $- Vesting of early exercised stock options$499 $- $- Conversion of convertible notes payable and accrued interest to Series A convertiblepreferred shares$- $2,682 $- 70CIDARA THERAPEUTICS, INCNotes to Consolidated Financial Statements — Continued See accompanying notes. CIDARA THERAPEUTICS, INC.Notes to Consolidated Financial Statements 1. THE COMPANY AND BASIS OF PRESENTATIONDescription of BusinessCidara Therapeutics, Inc., or the Company, was originally incorporated in Delaware in December 2012 as K2 Therapeutics, Inc., and its name waschanged to Cidara Therapeutics, Inc. in July 2014. The Company is a biotechnology company focused on the discovery, development andcommercialization of novel anti-infectives. The Company’s initial product portfolio is comprised of proprietary product candidates for the treatmentof serious fungal infections.On April 2, 2015, the Company’s board of directors and stockholders approved a 1-for-25.4 reverse stock split of its outstanding commonstock. The accompanying financial statements and notes to the financial statements give retroactive effect to the reverse stock split for allperiods presented.On April 20, 2015, the Company completed its initial public offering (“IPO”), whereby the Company sold 4,800,000 shares of common stock at aprice of $16.00 per share. Proceeds from the IPO were approximately $69.3 million, net of underwriting discounts and commissions and offeringcosts. In connection with the IPO, the outstanding shares of the Company’s Series A convertible preferred stock (“Series A preferred”) and SeriesB convertible preferred stock (“Series B preferred”) automatically converted into 7,561,380 shares of common stock.Basis of PresentationThe Company has a limited operating history and the sales and income potential of the Company’s business and market are unproven. Theaccompanying financial statements have been prepared assuming the Company will continue as a going concern, which contemplates therealization of assets and the satisfaction of liabilities in the normal course of business. The Company has experienced net losses and negativecash flows from operating activities since its inception. At December 31, 2015, the Company had an accumulated deficit of $45.5 million. TheCompany expects to continue to incur net losses into the foreseeable future. Successful transition to attaining profitable operations is dependentupon achieving a level of revenues adequate to support the Company’s cost structure. The Company plans to continue to fund its losses fromoperations and capital funding needs through debt and equity financing or through collaborations or partnerships with other companies. Debt orequity financing or collaborations and partnerships with other companies may not be available on a timely basis on terms acceptable to theCompany, or at all. If the Company is not able to secure adequate additional funding, the Company may be forced to make reductions in spending,extend payment terms with suppliers, liquidate assets where possible, or suspend or curtail planned programs. Any of these actions couldmaterially harm the Company’s business, results of operations and future prospects.Use of Estimates—The preparation of financial statements in conformity with U.S. generally accepted accounting principles, or GAAP, requiresmanagement to make estimates and assumptions that affect the reported amounts of assets, liabilities, and the disclosure of contingent assetsand liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. The Company evaluates itsestimates and assumptions on an ongoing basis. The most significant estimates in the Company’s financial statements relate to estimating thefair value of the Company’s common shares used to account for share-based compensation and certain accruals, including those related topreclinical and clinical activities. Although the estimates are based on the Company’s knowledge of current events, comparable companies, andactions it may undertake in the future, actual results may ultimately materially differ from these estimates and assumptions.Segment Information—Operating segments are identified as components of an enterprise about which separate discrete financial information isavailable for evaluation by the chief operating decision maker, the Chief Executive Officer, in making decisions regarding resource allocation andassessing performance. The Company views its operations and manages its business as one operating segment. 71CIDARA THERAPEUTICS, INCNotes to Consolidated Financial Statements — Continued 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIESCash and Cash Equivalents—The Company considers all short-term investments purchased with a maturity of three months or less whenacquired to be cash equivalents.Investments Available-for-Sale— Available-for-sale securities are carried at fair value, with the unrealized gains and losses reported inaccumulated other comprehensive income (loss). The amortized cost of debt securities is adjusted for amortization of premiums and accretion ofdiscounts to maturity. The amortization of premiums and accretion of discounts is included in interest income. Realized gains and losses anddeclines in value judged to be other-than-temporary, if any, on available-for-sale securities are included in other income (expense). The cost ofsecurities sold is based on the specific identification method. Interest and dividends on securities classified as available-for-sale are included ininterest income. Securities with maturity dates of 12 months or less from the date of purchase are classified as short-term investments andsecurities with maturity dates of more than 12 months are classified as long-term investments.Property and Equipment— We carry our property and equipment at cost, which consists of lab equipment, computer equipment and software,office equipment, furniture and fixtures and leasehold improvements. Property and equipment is depreciated using the straight-line method overthe estimated useful lives (generally three to seven years). Leasehold improvements are amortized over the lesser of their useful life or theremaining lease term, including any renewal periods that are deemed to be reasonably assured. Repair and maintenance costs are expensed asincurred.Concentration of Credit Risk—The Company’s financial instruments that are exposed to concentrations of credit risk consist primarily of cashand cash equivalents and short-term investments. Periodically, the Company maintains deposits in government insured financial institutions inexcess of government insured limits. The Company invests its cash balances in financial institutions that it believes have high credit quality andhas not experienced any losses on such accounts and does not believe it is exposed to significant credit risk.Patent Costs— The Company expenses all costs as incurred in connection with patent applications (including direct application fees, and the legaland consulting expenses related to making such applications) and such costs are included in general and administrative expenses in theaccompanying statements of operations.Convertible Preferred Stock—The Company’s Series A preferred and Series B preferred were classified as temporary equity instead ofstockholders’ equity (deficit) in accordance with authoritative guidance for the classification and measurement of potentially redeemable securitiesas the stock was conditionally redeemable at the holder’s option upon certain change in control events that were outside the Company’s control,including the liquidation, sale, or transfer of control of the Company. All of the outstanding Series A Preferred and Series B Preferred wasconverted to common upon the IPO in April 2015.Income Taxes—The Company follows the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 740,Income Taxes, or ASC 740, in reporting deferred income taxes. The ASC 740 requires a company to recognize deferred tax assets and liabilitiesfor expected future income tax consequences of events that have been recognized in the Company’s financial statements. Under this method,deferred tax assets and liabilities are determined based on temporary differences between financial statement carrying amounts and the tax basisof assets and liabilities using enacted tax rates in the years in which the temporary differences are expected to reverse. Valuation allowances areprovided if, based on the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized.The Company accounts for uncertain tax positions pursuant to ASC 740, which prescribes a recognition threshold and measurement process forfinancial statement recognition of uncertain tax positions taken or expected to be taken in a tax return. If the tax position meets this threshold, thebenefit to be recognized is measured as the tax benefit having the highest likelihood of being realized upon ultimate settlement with the taxingauthority. The Company recognizes interest accrued related to unrecognized tax benefits and penalties in the provision for income taxes.Research and Development Costs—Research and development expenses consist of wages, benefits and stock-based compensation charges forresearch and development employees, scientific consultant fees, facilities and overhead expenses, laboratory supplies, manufacturing expenses,and preclinical and clinical trial costs. The72CIDARA THERAPEUTICS, INCNotes to Consolidated Financial Statements — Continued Company accrues clinical trial expenses based on work performed which relies on estimates of total costs incurred based on patient enrollment,completion of studies, and other events.Costs incurred in purchasing technology assets and intellectual property are charged to research and development expense if the technology hasnot been conclusively proven to be feasible and has no alternative future use.Comprehensive Loss—Comprehensive loss is defined as the change in equity during a period from transactions and other events and/orcircumstances from non-owner sources. The Company’s only component of other comprehensive loss is unrealized gains (losses) on short-termmarketable securities. Comprehensive gains (losses) have been reflected in the statements of operations and comprehensive loss and as aseparate component of the statements of convertible preferred stock and stockholders’ equity (deficit) for all periods presented.Stock-based Compensation— The Company accounts for stock-based compensation expense related to employee stock options, restrictedstock grants, and employee stock purchase plan rights by estimating the fair value on the date of grant using the Black-Scholes option pricingmodel. For awards subject to time-based vesting conditions, stock-based compensation expense is recognized ratably over the requisite serviceperiod of the awards, net of estimated forfeitures. The Company accounts for stock options granted to non-employees using the fair valueapproach. These option grants are subject to periodic revaluation over their vesting terms.Net Loss Per Share—Basic net loss per share is computed by dividing the net loss by the weighted-average number of common sharesoutstanding for the period, without consideration for potentially dilutive securities. Diluted net loss per share is computed by dividing the net lossby the weighted-average number of common shares and dilutive common stock equivalents outstanding for the period determined using thetreasury-stock and if-converted methods. Dilutive common stock equivalents are comprised of convertible preferred stock, convertible notespayable, unvested restricted common stock subject to repurchase, and options outstanding under the Company’s stock option plan. For all periodspresented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding.The following table sets forth the outstanding potentially dilutive securities that have been excluded in the calculation of diluted net loss per sharebecause to do so would be anti-dilutive (in common stock equivalent shares): December 31, 2015 2014 Convertible preferred stock - 3,839,604 Common stock options issued and outstanding 1,437,583 709,136 Common stock subject to repurchase 156,235 361,768 Total 1,593,818 4,910,508 Fair Value of Financial Instruments— The Company follows authoritative guidance with respect to fair value reporting issued by the FASB forfinancial assets and liabilities, which defines fair value, provides guidance for measuring fair value and requires certain disclosures. The guidancedoes not apply to measurements related to share-based payments. The guidance discusses valuation techniques such as the market approach(comparable market prices), the income approach (present value of future income or cash flow), and the cost approach (cost to replace the servicecapacity of an asset or replacement cost). The guidance establishes a fair value hierarchy that prioritizes the inputs to valuation techniques usedto measure fair value into three broad levels.The Company’s financial instruments consist of cash and cash equivalents, marketable securities, prepaid expenses, accounts payable, andaccrued liabilities. Fair value estimates of these instruments are made at a specific point in time based on relevant market information. Theseestimates may be subjective in nature and involve uncertainties and matters of significant judgment and therefore cannot be determined withprecision. The carrying amount of cash and cash equivalents, prepaid expenses, accounts payable, and accrued liabilities are generallyconsidered to be representative of their respective fair values because of the short-term nature of those instruments. The fair value of marketablesecurities is based upon market prices quoted on the last day of the fiscal period or other observable market inputs.73CIDARA THERAPEUTICS, INCNotes to Consolidated Financial Statements — Continued Recently Issued Accounting Standards— During 2014, the FASB issued Accounting Standards Update (“ASU”) 2014-15, “Presentation ofFinancial Statements—Going Concern.” The update requires management to assess an entity’s ability to continue as a going concern and toprovide related footnote disclosure in certain circumstances. The update is effective for annual reporting periods ending after December 15, 2016and interim periods thereafter. Early application is permitted. The Company is currently assessing the impact that this standard will have on itsfinancial statements.During 2015, the FASB issued ASU 2015-17, “Income Taxes: Balance Sheet Classification of Deferred Taxes,” which amends existing guidance torequire companies to classify deferred tax assets and liabilities as noncurrent in the statement of financial position. The update is effective forannual periods beginning after December 15, 2016, and early adoption is permitted. The update may be adopted on either a prospective orretrospective basis. The Company adopted ASU 2015-17 in the fourth quarter of 2015 on a retrospective basis. The adoption of this guidance didnot have a material impact on the Company’s financial statements.During 2016, the FASB issued ASU 2016-02, “Leases,” which requires that lease arrangements longer than 12 months result in an entityrecognizing an asset and liability. The updated guidance is effective for interim and annual periods beginning after December 15, 2018, and earlyadoption is permitted. The Company is currently assessing the impact that this standard will have on its financial statements. 3. SHORT-TERM INVESTMENTSThe following table summarizes the available-for-sale securities held at December 31, 2015 (in thousands): Amortized Cost UnrealizedGains UnrealizedLosses Fair Value Certificates of deposit$20,000 $- $- $20,000 Commercial paper 24,960 - (8) $24,952 Total$44,960 $- $(8) $44,952 All available-for-sale securities held at December 31, 2015 will mature in less than one year.At December 31, 2014, the Company had no available-for-sale securities. 4. FAIR VALUE MEASUREMENTSThe Company follows ASC 820-10, Fair Value Measurements and Disclosures, which among other things, defines fair value, establishes aconsistent framework for measuring fair value and expands disclosure for each major asset and liability category measured at fair value on either arecurring or nonrecurring basis. Fair value is an exit price, representing the amount that would be received to sell an asset or paid to transfer aliability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determinedbased on assumptions that market participants would use in pricing an asset or liability.As a basis for considering such assumptions, a three-tier fair value hierarchy has been established, which prioritizes the inputs used in measuringfair value as follows:Level 1: Observable inputs such as quoted prices (unadjusted) in active markets for identical assets or liabilities;Level 2: Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly; andLevel 3: Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions,which reflect those that a market participant would use.At December 31, 2015, the Company held certificates of deposit, which are valued at cost, and commercial paper, which is valued usingobservable market inputs including reported trades, broker/dealer quotes, bids and/or offers. 74CIDARA THERAPEUTICS, INCNotes to Consolidated Financial Statements — Continued At December 31, 2015 and 2014, the Company held securities of a money market fund which invested in short-term U.S. Treasury securities, theprices of which were available from quoted prices in active markets.None of the Company’s non-financial assets or liabilities are recorded at fair value on a non-recurring basis. No transfers between levels haveoccurred during the periods presented.The following tables summarize the Company’s financial instruments measured at fair value on a recurring basis: TOTAL LEVEL 1 LEVEL 2 LEVEL 3 December 31, 2015 Assets: Cash equivalents and money market funds$12,353 $12,353 $- $- Certificates of deposit included in cash and cashequivalents 50,000 - 50,000 - Certificates of deposit included in short-terminvestments 20,000 - 20,000 - Commercial paper 24,952 - 24,952 - Total assets at fair value$107,305 $12,353 $94,952 $- December 31, 2014 Assets: Cash equivalents and money market funds$20,769 $20,769 $- $- Total assets at fair value$20,769 $20,769 $- $- 5. PROPERTY AND EQUIPMENTProperty and equipment consisted of the following (in thousands): December 31, 2015 2014 Laboratory equipment$1,438 $687 Leasehold improvements 425 94 Computer hardware and software 242 210 Office equipment 111 42 Furniture and fixtures 105 9 2,321 1,042 Less accumulated depreciation and amortization (637) (179)Total$1,684 $863 Depreciation and amortization of property and equipment of $461,000 and $179,000 was recorded for the years ended December 31, 2015 and2014, respectively. 6. DEBT2013 Convertible Notes PayableDuring 2013, the Company issued convertible notes (the 2013 Notes) to a major shareholder of the Company, 5AM Ventures, for an aggregate of$1,250,000. The 2013 Notes bore interest at 8%, which compounded annually. The 2013 Notes were convertible into preferred shares of theCompany’s equity securities at a 15% discount to the sales price of the equity securities sold at the next financing or a series of relatedtransactions yielding gross proceeds to the Company of at least $13,750,000 (defined as a Qualified Financing). The 2013 Notes were to matureon the earlier of a Qualified Financing, a change in control, or February 8, 2014, or such later date as provided for by the written consent of thenote holders. In January 2014, the holders of the 2013 Notes executed a written consent to extend the maturity date of the 2013 Notes to July 30,2014.75CIDARA THERAPEUTICS, INCNotes to Consolidated Financial Statements — Continued 2014 Convertible Notes PayableIn January and February 2014, the Company issued convertible notes (the 2014 Notes) to 5AM Ventures and certain non-affiliated investors for$500,000 and $450,000, respectively. The 2014 Notes bore interest at 8%, which compounded annually. The 2014 Notes were convertible intopreferred shares of the Company’s equity securities at a 15% discount to the sales price of the equity securities sold in a Qualified Financing. The2014 Notes were to mature on the earlier of a Qualified Financing, a change in control, or July 30, 2014, or such later date as provided for by thewritten consent of the note holdersOn May 30, 2014, the outstanding principal balance of both the 2013 Notes and the 2014 Notes plus all accrued interest thereon converted into321,492 shares of Series A Preferred, which were converted to common stock upon the Company’s IPO in April, 2015. 7. STOCKHOLDERS’ EQUITYPreferred Stock—The Company has 10,000,000 shares of preferred stock authorized at December 31, 2015. The Company had no shares ofpreferred stock issued or outstanding at December 31, 2015.Under the amended and restated certificate of incorporation, the Company’s board of directors has the authority, without further action by thestockholders, to issue up to 10,000,000 shares of preferred stock in one or more series, to establish from time to time the number of shares to beincluded in each such series, to fix the rights, preferences and privileges of the shares of each wholly unissued series and any qualifications,limitations or restrictions thereon and to increase or decrease the number of shares of any such series, but not below the number of shares ofsuch series then outstanding.Common Stock—The Company had 200,000,000 shares of common stock authorized as of December 31, 2015. Holders of outstanding shares ofcommon stock are entitled to one vote for each share held of record on all matters submitted to a vote of the holders of common stock. Subject tothe rights of the holders of any class of the Company’s capital stock having any preference or priority over common stock, the holders of commonstock are entitled to receive dividends that are declared by the Company’s board of directors out of legally available funds. In the event of aliquidation, dissolution or winding-up, the holders of common stock are entitled to share ratably in the net assets remaining after payment ofliabilities, subject to prior rights of preferred stock, if any, then outstanding. The common stock has no preemptive rights, conversion rights,redemption rights or sinking fund provisions, and there are no dividends in arrears or default. All shares of common stock have equal distribution,liquidation and voting rights, and have no preferences or exchange rights. 8. EQUITY INCENTIVE PLANS2015 Equity Incentive PlanIn March 2015, the Company’s board of directors and stockholders approved and adopted the 2015 Equity Incentive Plan (“2015 EIP”). Under the2015 EIP, the Company may grant stock options, stock appreciation rights, restricted stock, restricted stock units, and other awards to individualswho are employees, officers, directors, or consultants of the Company. A total of 1,829,020 shares of common stock were reserved for issuanceunder the 2015 EIP. The number of shares of stock available for issuance under the 2015 EIP will be automatically increased each January 1,beginning on January 1, 2016, by 4% of the outstanding number of shares of the Company’s common stock on the immediately precedingDecember 31 or such lesser number as determined by the Company’s board of directors.Terms of stock award agreements, including vesting requirements, are determined by the board of directors, subject to the provisions of the 2015EIP. Stock options granted by the Company generally vest over a three- or four-year year period. Certain stock options are subject to accelerationof vesting in the event of certain change of control transactions. The stock options may be granted for a term of up to ten years from the date ofgrant. The exercise price for stock options granted under the 2015 EIP must be at a price no less than 100% of the estimated fair value of theshares on the date of grant as determined by the board of directors, provided that for an incentive stock option granted to an employee who at thetime of grant owns stock representing more than 10% of the voting power of all classes of stock of the Company, the exercise price shall be noless than 110% of76CIDARA THERAPEUTICS, INCNotes to Consolidated Financial Statements — Continued the estimated value on the date of grant. As of December 31, 2015, the Company had 1,788,396 shares available for future issuance toemployees, nonemployee directors, and consultants of the Company under the 2015 EIP.2015 Employee Stock Purchase PlanIn March 2015, the Company’s board of directors and stockholders approved and adopted the 2015 Employee Stock Purchase Plan (“ESPP”). Atotal of 245,168 shares of common stock were initially reserved for issuance under the ESPP. In addition, the number of shares of stock availablefor issuance under the ESPP will be automatically increased each January 1, beginning on January 1, 2016, by the lesser of (i) 1% of theoutstanding number of shares of the Company’s common stock on the immediately preceding December 31, or (ii) 490,336 shares.The ESPP allows substantially all employees to purchase the Company’s common stock through a payroll deduction at a price equal to 85% ofthe lower of the fair market value of the stock as of the beginning or the end of each purchase period. An employee’s payroll deductions under theunder the ESPP are limited to 15% of the employee’s eligible compensation. During the year ended December 31, 2015, 19,164 shares wereissued pursuant to the ESPP.Restricted StockThe Company permits early exercise of certain stock options. Any unvested shares are restricted and subject to repurchase by the Company untilthe conditions for vesting are met. At December 31, 2015 and 2014, the liabilities for the cash received from the early exercise of stock optionswere $341,000 and $736,000, respectively, and were classified in accrued liabilities on the balance sheet. The Company reduces the liability asthe underlying shares vest in accordance with the vesting terms outlined in the stock option agreements which, generally, is 4 years. At December31, 2015, 156,235 unvested shares were subject to repurchase by the Company.Stock OptionsThe following table summarizes stock option activity during the year ended December 31, 2015: Number ofShares WeightedAverageExercise Price WeightedAverageRemainingContractualLifein Years TotalAggregateIntrinsic Value Outstanding at December 31, 2014 709,136 $2.29 9.73 $2,522 Options granted 899,728 8.56 Options exercised (67,468) 2.40 Options canceled (103,813) 2.58 Outstanding at December 31, 2015 1,437,583 $6.19 8.94 $15,774 Vested and expected to vest at December 31, 2015 1,437,583 $6.19 8.94 $15,774 Vested at December 31, 2015 809,879 $2.82 8.38 $11,615 Exercisable at December 31, 2015 1,114,318 $5.19 8.98 $13,342 77CIDARA THERAPEUTICS, INCNotes to Consolidated Financial Statements — Continued The following table summarizes the Black-Scholes option pricing model assumptions used to estimate the fair value of stock options granted toemployees under our equity incentive plans and the shares purchasable under our 2015 ESPP during the periods presented: For the years ended December 31, 2015 2014 2015 EIP Risk-free interest rate1.53% - 1.91% 0.04% - 1.98% Expected dividend yield 0% 0% Expected volatility78% - 80% 71% - 78% Expected term (years)5.00 - 6.08 5.00 - 6.08 2015 ESPP Risk-free interest rate0.35% - 0.94% - Expected dividend yield 0% - Expected volatility65% - 101% - Expected term (years)0.50 - 2.00 - Stock-based compensation expense recognized for stock options and the ESPP has been reported in the statements of operations andcomprehensive loss as follows (in thousands): Years ended December 31, 2015 2014 Research and development$1,586 $108 General and administrative 1,447 124 Total$3,033 $232 The weighted-average grant date fair value of stock options granted to employees during the year ended December 31, 2015 was $5.81 per share.The total grant date fair value of stock options that vested during the year ended December 31, 2015 was $2.2 million. As of December 31, 2015,total unrecognized share-based compensation expense related to unvested employee stock options of the Company was approximately $4.7million. This unrecognized compensation cost is expected to be recognized over a weighted-average period of approximately 2.7 years.As of December 31, 2015, total unrecognized compensation expense related to the Company’s ESPP was approximately $0.5 million. Thisunrecognized compensation cost is expected to be recognized over approximately 1.9 years.Common Stock Reserved for Future IssuanceCommon stock reserved for future issuance is as follows (in common stock equivalent shares): Years ended December 31, 2015 2014 Conversion of Series A preferred - 3,839,604 Stock options issued and outstanding 1,437,583 709,136 Authorized for future stock awards 1,788,396 12,062 Awards available under the ESPP 226,004 - Total 3,451,983 4,560,802 78CIDARA THERAPEUTICS, INCNotes to Consolidated Financial Statements — Continued 9. INCOME TAXESThe Company accounts for income taxes under ASC 740. Deferred income tax assets and liabilities are determined based upon differencesbetween financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effectwhen the differences are expected to reverse.The following table provides a reconciliation between income taxes computed at the federal statutory rate of 34% and the provision for incometaxes (in thousands): Years Ended December 31, 2015 2014 2013 Federal income taxes at 34%$(10,946)$(4,044)$(457)State income tax, net of federal benefit (1,821) (672) (62)Tax effect on nondeductible expenses 341 132 80 Research credits (676) (265) (18)Change in valuation allowance 13,084 4,849 457 Other 18 - - Income tax expense$- $- $- Significant components of the Company’s net deferred tax assets are as follows (in thousands): Years Ended December 31, 2015 2014 2013 Deferred tax assets: Net operating losses$15,646 $4,187 $433 Research credits 987 283 - Intangibles 590 635 - Other 1,231 226 49 Total deferred tax assets 18,454 5,331 482 Less valuation allowance (18,454) (5,331) (482)Income tax expense$- $- $- At December 31, 2015, the Company had federal and state net operating loss carryforwards of approximately $39.3 million and $39.4 million,respectively. The federal and state loss carryforwards begin to expire in 2033, unless previously utilized. The Company also has federal and stateresearch and development credit carryforwards totaling $1.0 million and $0.5 million, respectively. The federal research and development creditcarryforwards begin to expire in 2033, unless previously utilized. The state research and development credit carryforwards begin to expire in 2028.Management assesses the available positive and negative evidence to estimate if sufficient future taxable income will be generated to use theexisting deferred tax assets. Based on the weight of all evidence, including a history of operating losses, management has determined that it ismore likely than not that the net deferred tax assets will not be realized. A valuation allowance of $18.5 million and $5.3 million as of December 31,2015 and 2014, respectively, has been established to offset the deferred tax assets as realization of such assets is uncertain.Future utilization of the Company’s net operating loss and research and development credits carryforwards to offset future taxable income may besubject to an annual limitation, pursuant to Internal Revenue Code (IRC) Sections 382 and 383, as a result of ownership changes that may haveoccurred or that could occur in the future. An ownership change occurs when a cumulative change in ownership of more than 50% occurs within athree-year period. The Company has not completed an IRC Section 382/383 analysis regarding the limitation of net operating loss and researchand development credit carryforwards.The Company recognizes a tax benefit from an uncertain tax position when it is more likely than not that the position will be sustained uponexamination, including resolutions of any related appeals or litigation processes, based on the technical merits. Income tax positions must meet amore likely than not recognition at the effective date to be recognized. At December 31, 2015 and 2014, the unrecognized tax benefits recordedwere approximately $356,000 and $108,000, respectively. Approximately $318,000 and $94,000 of the unrecognized79CIDARA THERAPEUTICS, INCNotes to Consolidated Financial Statements — Continued tax benefits for the years ended December 31, 2015 and 2014, respectively, would reduce our annual effective tax rates, if recognized, subject tothe valuation allowances. The Company does not anticipate a significant change in the unrecognized tax benefits within the next 12 months.A reconciliation of the beginning and ending amount of gross unrecognized tax benefits for 2015, 2014 and 2013 is as follows (in thousands): Years Ended December 31, 2015 2014 2013 Balance as of the beginning of the year$108 $6 $- Increases related to current year tax positions 248 102 6 Balance as of the end of the year$356 $108 $6 The Company files tax returns as prescribed by the tax laws of the jurisdictions in which it operates. In the normal course of business, theCompany is subject to examination by the United States and state jurisdictions where applicable. There are currently no pending income taxexaminations. The Company’s tax years from inception in 2012 are subject to examination by the federal and state tax authorities due to thecarryforward of unutilized net operating losses and research and development credits. The Company’s practice is to recognize interest andpenalties related to income tax matters in income tax expense. The Company has not recognized interest or penalties since inception. 10. COMMITMENTS AND CONTINGENCIESLitigation—From time to time, the Company may be involved in various lawsuits, legal proceedings, or claims that arise in the ordinary course ofbusiness. Management believes there are no claims or actions pending against the Company at December 31, 2015 which will have, individually orin the aggregate, a material adverse effect on its business, liquidity, financial position, or results of operations. Litigation, however, is subject toinherent uncertainties, and an adverse result in such matters may arise from time to time that may harm the Company’s business.Lease Obligations—In June 2014, the Company entered into an operating lease agreement for laboratory and office space in San Diego,California. Amendments for additional space were entered into in February 2015, March 2015 and August 2015. The lease expires in December2018 with options for two individual two-year extensions. The lease is subject to charges for common area maintenance and other costs, and baserent is subject to 3% annual increases every July. Rent expense is being recorded on a straight-line basis over the life of the lease.Future minimum payments required under the lease as of December 31, 2015 are summarized as follows (in thousands): 2016$704 2017 725 2018 747 Total minimum lease payments$2,176 Rent expense was $581,000 and $182,000 for the years ended December 31, 2015 and 2014, respectively.Contractual Obligations—The Company enters into contracts in the normal course of business with vendors for research and developmentactivities, manufacturing, and professional services. These contracts generally provide for termination either on or within 30 days of notice. 80CIDARA THERAPEUTICS, INCNotes to Consolidated Financial Statements — Continued 11. SELECTED QUARTERLY FINANCIAL DATA (UNAUDITED) FirstQuarter SecondQuarter ThirdQuarter FourthQuarter 2015 Operating expenses$6,732 $6,446 $9,207 $9,928 Other income (expense) (5) 32 33 60 Net loss (6,737) (6,414) (9,174) (9,868)Basic and diluted net loss per share$(5.92) $(0.59) $(0.67) $(0.72)Shares used to compute basic and diluted net loss per share 1,138,911 10,957,150 13,674,568 13,731,519 2014 Operating expenses$559 $3,095 $3,320 $4,649 Other income (expense) (148) (124) 1 - Net loss (707) (3,219) (3,319) (4,649)Basic and diluted net loss per share$(1.81) $(5.04) $(2.98) $(4.13)Shares used to compute basic and diluted net loss per share 389,839 638,272 1,113,439 1,126,707 81 Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure.None. Item 9A. Controls and Procedures.Evaluation of Disclosure Controls and ProceduresWe maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our periodic and currentreports that we file with the SEC is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms,and that such information is accumulated and communicated to our management, including our chief executive officer and principal financialofficer, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures,management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable and notabsolute assurance of achieving the desired control objectives. In reaching a reasonable level of assurance, management necessarily wasrequired to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures. In addition, the design of any systemof controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design willsucceed in achieving its stated goals under all potential future conditions; over time, control may become inadequate because of changes inconditions, or the degree of compliance with policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective controlsystem, misstatements due to error or fraud may occur and not be detected.As of December 31, 2015, we carried out an evaluation, under the supervision and with the participation of our management, including our principalexecutive officer and principal financial officer, of the effectiveness of the design and operation of our disclosure controls and procedures, asdefined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act. Based on this evaluation, our principal executive officer and principal financialofficer concluded that our disclosure controls and procedures were effective at the reasonable assurance level as of December 31, 2015.Management’s Report on Internal Control over Financial Reporting.This Annual Report does not include a report of management's assessment regarding internal control over financial reporting or an attestationreport of our registered public accounting firm due to a transition period established by rules of the Securities and Exchange Commission for newlypublic companies.Changes in Internal Control over Financial ReportingThere were no changes in our internal control over financial reporting that occurred during our latest fiscal quarter that have materially affected, orare reasonably likely to materially affect, our internal control over financial reporting. Item 9B. Other Information.On March 16, 2016, our compensation committee approved an amended and restated bonus plan, which became effective on January 1, 2016,and our board of directors, upon recommendation of our compensation committee, approved the elements of the bonus plan applicable to our chiefexecutive officer. All of our employees, including our named executives, are eligible to participate in the bonus plan. The target bonuspercentages that Jeffrey Stein, Ph.D., our President and Chief Executive Officer, Dirk Thye, M.D., our Chief Medical Officer, Kevin Forrest, Ph.D.,our Chief Financial Officer and Chief Operating Officer, and Kenneth Bartizal, Ph.D., our Chief Development Officer, are eligible for under thebonus plan are initially 50%, 35%, 35% and 35% of their base salary, respectively. Dr. Stein’s bonus award is weighted 100% for our achievementof corporate goals to be established by the compensation committee. The bonus awards for Drs. Thye, Forrest and Bartizal are weighted 80% forour achievement of corporate goals and 20% for achievement of individual goals, to be approved by our chief executive officer. For our executiveofficers, including our named executive officers, the actual bonus award for any year, if any, may be more or less than the applicable target,depending primarily on the compensation committee’s determination of an award multiplier for the corporate goal component and the executive’sindividual performance with respect to such corporate goals. Payments under the bonus plan may be made in cash, through the issuance of stock,stock options or another form of equity award, or by a combination thereof. The compensation committee has the right to terminate or change theplan at any time and for any reason.82 Also on March 16, 2016, our board of directors, based on the recommendation of our compensation committee, approved an increase in the annualbase salary for Dr. Stein to $430,000, and our compensation committee approved increases in the annual base salaries for Dr. Thye to $385,000,for Dr. Forrest to $310,000 and for Dr. Bartizal to $325,000. These increased annual base salaries are effective as of January 1, 2016.Prior to the increases in annual base salary, our executive officers’ annual base salaries approximated the 10th percentile of our peer group. Ourcompensation philosophy is to approximate the 50th percentile of our peer group as identified by our outside compensation consultant andapproved by the Compensation Committee of the Board of Directors. The new annual base salaries approximate the 25th to 50th percentile, whichis more closely aligned with our compensation philosophy. 83 PART IIIItem 10. Directors, Executive Officers and Corporate Governance.The information required by this item and not set forth below will be set forth in the section headed “Election of Directors” and “Executive Officers”in our Proxy Statement for our 2016 Annual Meeting of Stockholders, or Proxy Statement, to be filed with the SEC within 120 days after the fiscalyear ended December 31, 2015, and is incorporated herein by reference.We have adopted a code of ethics for directors, officers (including our principal executive officer, principal financial officer and principal accountingofficer) and employees, known as the Code of Business Conduct and Ethics. The Code of Business Conduct and Ethics is available on ourwebsite at http://www.cidara.com under the Corporate Governance section of our Investor Relations page. We will promptly disclose on ourwebsite (i) the nature of any amendment to the policy that applies to our principal executive officer, principal financial officer, principal accountingofficer, or persons performing similar functions and (ii) the nature of any waiver, including an implicit waiver, from a provision of the policy that isgranted to one of these specified individuals that is required to be disclosed pursuant to SEC rules and regulations, the name of such person whois granted the waiver and the date of the waiver. The information contained on, or that can be accessed through, our website is not part of thisAnnual Report, and the inclusion of our website address in this Annual Report is an inactive textual reference only Item 11. Executive Compensation.The information required by this item will be set forth in the section headed “Executive and Director Compensation” in our Proxy Statement and isincorporated herein by reference. Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.The information required by this item will be set forth under the headings “Equity Benefit Plans” and “Security Ownership of Certain BeneficialOwners and Management” in our Proxy Statement and is incorporated herein by reference.The information required by Item 201(d) of Regulation S-K will be set forth in the section headed “Executive and Director Compensation” in ourProxy Statement and is incorporated herein by reference. Item 13. Certain Relationships and Related Transactions, and Director Independence.The information required by this item will be set forth in the section headed “Certain Relationships and Related Party Transactions” in our ProxyStatement and is incorporated herein by reference. Item 14. Principal Accounting Fees and Services.The information required by this item will be set forth in the section headed “Principal Accountant Fees and Services” in our Proxy Statement andis incorporated herein by reference. 84 PART IVItem 15. Exhibits, Financial Statement Schedules. 1.Financial Statements—We have filed the following documents as part of this Annual Report: PageReport of Independent Registered Public Accounting Firm 66Balance Sheets 67Statements of Operations and Comprehensive Loss 68Statements of Convertible Preferred Stock and Stockholders’ Equity (Deficit) 69Statements of Cash Flows 70Notes to Financial Statements 71 2.Financial Statement Schedules—All other schedules are omitted because they are not required or the required information is includedin the financial statements or notes thereto. 3.Exhibits—For a list of exhibits filed with this Annual Report, refer to the exhibit index following the signature page on this AnnualReport. 85 SIGNATURESPursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused thisReport to be signed on its behalf by the undersigned, thereunto duly authorized. Cidara Therapeutics, Inc. Date: March 17, 2016 By: /s/ Jeffrey Stein, Ph.D. Jeffrey Stein, Ph.D. President and Chief Executive OfficerPOWER OF ATTORNEYKNOW ALL BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Jeffrey Stein, Ph.D. and KevinForrest, Ph.D., and each of them, as his or her true and lawful attorneys-in-fact and agents, each with the full power of substitution, for him or herand in his or her name, place or stead, in any and all capacities, to sign any and all amendments to this report, and to file the same, with allexhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-factand agents, and each of them, full power and authority to do and perform each and every act and thing requisite and necessary to be done in andabout the premises, as fully to all intents and purposes as he or she might or could do in person, hereby ratifying and confirming all that saidattorneys-in-fact and agents, or either of them, or his or her substitute or substitutes, may lawfully do or cause to be done by virtue hereof.Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, this Report has been signed below by the following persons onbehalf of the Registrant in the capacities and on the dates indicated. Name Title Date /s/ Jeffrey Stein, Ph.D. President and Chief Executive Officer March 17, 2016Jeffrey Stein, Ph.D. (Principal Executive Officer) /s/ Kevin Forrest, Ph.D. Chief Operating Officer and Chief Financial Officer March 17, 2016Kevin Forrest, Ph.D. (Principal Financial Officer) /s/ Marc J.S. Wilson Vice President, Finance and Accounting March 17, 2016Marc J.S. Wilson (Principal Accounting Officer) /s/ Scott M. Rocklage, Ph.D Chairman of the Board of Directors March 17, 2016Scott M. Rocklage, Ph.D /s/ Daniel D. Burgess Member of the Board of Directors March 17, 2016Daniel D. Burgess /s/ Timothy R. Franson, M.D. Member of the Board of Directors March 17, 2016Timothy R. Franson, M.D. /s/ Robert J. Perez Member of the Board of Directors March 17, 2016Robert J. Perez /s/ Theodore R. Schroeder Member of the Board of Directors March 17, 2016Theodore R. Schroeder 86 Exhibit Index ExhibitNumber Description3.1(1) Amended and Restated Certificate of Incorporation of the Registrant, as currently in effect.3.2(1) Amended and Restated Bylaws of the Registrant, as currently in effect.4.1(2) Form of Common stock Certificate of the Registrant.4.2(2) Second Amended and Restated Investor Rights Agreement, by and among the Registrant and certain of its stockholders, datedFebruary 10, 2015.4.3(2) Warrant to Purchase Stock issued to Comerica Bank, dated December 29, 2014.10.1+(2) Form of Indemnity Agreement by and between the Registrant and its directors and officers.10.2+(3) 2015 Equity Incentive Plan and Form of Grant Notice, Stock Option Agreement and Notice of Exercise thereunder.10.3+(2) 2015 Employee Stock Purchase Plan.10.4+(2) 2013 Stock Option and Grant Plan and Form of Stock Option Agreement, Notice of Exercise and Stock Option Grant Noticethereunder, as amended.10.5+(2) Amended and Restated Employment Letter Agreement by and between the Registrant and Jeffrey Stein, Ph.D., dated July 12,2014.10.6+(2) Amended and Restated Employment Letter Agreement by and between the Registrant and Kevin Forrest, Ph.D., dated July 18,2014.10.7+(2) Employment Letter Agreement by and between the Registrant and Ken Bartizal, Ph.D., dated June 26, 2014.10.8+(2) Employment Letter Agreement by and between the Registrant and Paul Daruwala, dated December 17, 2014.10.9+(2) Employment Letter Agreement by and between the Registrant and Dirk Thye, M.D., dated July 15, 2014.10.10(2) Loan and Security Agreement by and between Registrant and Comerica Bank, dated December 29, 2014.10.11(2) Asset Purchase Agreement by and between Registrant and Seachaid Pharmaceuticals, Inc., dated May 30, 2014.10.12(2) Addendum to Asset Purchase Agreement by and between Registrant and Seachaid Pharmaceuticals, Inc. dated September 23,2014 and deemed effective as of May 30, 2014.10.13(2) Standard Industrial/Commercial Multi-Tenant Lease by and between the Registrant and Nancy Ridge Technology Center, L.P.,dated June 9, 2014.10.14(2) First Amendment to Lease by and between the Registrant and Nancy Ridge Technology Center, L.P., dated June 9, 2014.10.15(2) Second Amendment to Lease by and between the Registrant and Nancy Ridge Technology Center, L.P., dated February 15, 2015.10.16+* Cidara Therapeutics, Inc. Bonus Plan.10.17(4) Third Amendment to Lease by and between the Registrant and Nancy Ridge Technology Center, L.P.,dated July 1, 2015.21.1* List of subsidiaries of the Registrant.23.1* Consent of Independent Registered Public Accounting Firm.24.1 Power of Attorney. Reference is made to the signature page hereto.31.1* Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934,as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.31.2* Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934,as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.32.1* Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of theSarbanes-Oxley Act of 2002.32.2* Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of theSarbanes-Oxley Act of 2002.101.INS XBRL Instance Document101.SCH XBRL Taxonomy Extension Schema Document101.CAL XBRL Taxonomy Extension Calculation Linkbase Document101.DEF XBRL Taxonomy Extension Definition Linkbase Document87 ExhibitNumber Description101.LAB XBRL Taxonomy Extension Label Linkbase Document101.PRE XBRL Taxonomy Extension Presentation Linkbase Document (1)Incorporated by reference to the Registrant’s Current Report on Form 8-K, filed on April 24, 2015.(2)Incorporated by reference to the Registrant’s Registration Statement on Form S-1 (File No. 333-202740), as amended, originally filed onMarch 13, 2015.(3)Incorporated by reference to the Registrant’s Registration Statement on Form S-8 (File No. 333-203434), filed on April 15, 2015.(4)Incorporated by reference to the Registrant’s Quarterly Report on Form 10-Q, filed on November 16, 2015.+Indicates management contract or compensatory plan.*Filed herewith. 88 EXHIBIT 10.16 CIDARA THERAPEUTICS, INC.BONUS PLAN Effective January 1, 2016 The Cidara Therapeutics, Inc. (“Cidara” or the “Company”) Bonus Plan (the “Plan”) is designed to reward eligible employees for theachievement of corporate objectives, as well as measured individual objectives that are consistent with and support the overall corporateobjectives. The Plan is designed to:·Encourage high performance by providing an incentive program to achieve overall corporate objectives.·Reward those individuals who significantly impact corporate results.·Encourage increased teamwork among all disciplines within Cidara.·Incorporate an incentive program in the overall compensation program to help attract and retain employees. ELIGIBILITYAll regular employees are eligible to participate in the Plan. In order to be eligible, a participant must have been in an eligible positionfor at least three (3) full months prior to the end of the Plan year, and the participant must remain employed through the end of the Planyear and until awards are paid. If the participant is not employed on the date awards are paid, the participant will not have earned anybonus. If the participant has been subject to any performance improvement plan or other disciplinary procedure during the Plan year,any award to such individual will be at the discretion of the President/CEO or the Compensation Committee of the Board of Directors(the “Compensation Committee”), and may be reduced or withheld regardless of corporate performance as outlined below. Change in Status During the Plan Period:a.Participants hired during the Plan year:·Participants hired during the Plan year are eligible for a prorated award based on the number of calendar days employed in aneligible position.·Participants hired during the months of October through December are not eligible to participate for the Plan year.·If an employee has worked in a temporary or consulting capacity for Cidara, this time will not impact the eligibility start datewhich is the date of hire. Only as an exception and with approval by the Compensation Committee or the Board of Directors willtime worked as a consultant be considered when determining the bonus award proration for an employee.b.Promotion/change in level:· If a promotion occurred during the first three quarters of the applicable Plan year, the positionat the end of the Plan year shall be used for the purposes of bonus calculation. · If a promotion occurred on or after October 1 of the applicable Plan year, the entire calculation will be based on the position prior to the promotion.c.Termination of employment:·If a participant’s employment is terminated voluntarily prior to the date awards are paid, the participant will not be eligible toreceive an award.·If a participant’s employment is terminated involuntarily prior to the date awards are paid, it will be at the absolute discretion ofthe Company whether or not an award payment is made.d.Leave of absence: ·Bonus award will be prorated to reflect the calendar days on a leave of absence that exceed 60 calendar days in the Plan year. 1 AWARD CALCULATIONAwards will be determined by applying a “bonus percentage” to the participant’s base salary that is in effect at the end of the Planyear. While the Compensation Committee may change the bonus percentage for any Plan year, the following bonus percentages willinitially be used for this purpose: Position TitleBonus PercentagePresident/CEO50%Chief Officer35%Vice President, Senior Vice President30%Senior Director, Executive Director25%Director20%Associate Director, Senior Principal Scientist15%Manager, Senior Manager, Scientist, Senior Scientist10%Analyst, Accountant, Executive Assistant, Research Associate8%Administrative Assistant, Accounting Associate6% Corporate and Individual Performance FactorsThe President/CEO will present to the Compensation Committee/Board of Directors a list of the overall corporate objectives for theapplicable Plan year, which are subject to approval by the Compensation Committee/Board of Directors. All participants in the Planwhose performance is measured in part based on individual performance factors will then develop a list of key individual objectives,which must be approved by the responsible Vice President, Senior Vice President, Chief Officer, or President/CEO. The relative weight between corporate and individual performance factors varies based on the individual’s assigned level within theorganization. The weighting may be reviewed periodically and may be adjusted for any Plan year. The weighting for the performancefactors will initially be as follows:CorporateIndividualPresident/CEO 100%Chief Officer 80% 20% Vice President, Sr Vice President 60% 40%Director, Sr Director, Exec Director 50% 50%Manager, Sr Mgr, Assoc Dir, Scientist 40% 60%Analyst/Associate/Administrative 30% 70% Performance Award MultiplierSeparate award multipliers will be established for both the corporate and the individual components of each award. The awardmultiplier for the corporate component will be determined by the Compensation Committee/Board of Directors each Plan year, in itssole discretion. The same award multiplier for the corporate component of the award shall be used for all such Plan participants. Theaward multiplier for the individual component shall be determined by the responsible Chief Officer or President/CEO. For Executives (Vice President level and above): The actual performance bonus awarded in any year, if any, may be more or less thanthe applicable target, depending primarily on the Compensation Committee’s determination of the award multiplier for the corporatecomponent and the executive’s individual performance with respect to the corporate objectives. Whether or not performance bonus ispaid for any year is within the discretion of the Compensation Committee/Board of Directors based on such achievement. 2 ExampleThe example below shows a sample cash bonus award calculation under the Plan, which is determined after the end of the performanceperiod. Step #1: A potential base bonus award is calculated by multiplying the employee’s base salary by their assigned level bonuspercentage. Step #2: The calculated potential base bonus amount is then split between the corporate and individual performance factors by theemployee’s assigned level (per the weighting above). This calculation establishes specific potential dollar awards for the performanceperiod based on both the individual and corporate performance factor components.Step #3: After the end of the performance period, corporate and individual award multipliers will be established using the criteriadescribed above. Awards are determined by multiplying the potential bonus awards in Step #2 by the actual corporate and individualaward multipliers. Example:Step # 1: Potential Bonus Award CalculationPosition: ManagerBase salary: $100,000Target bonus percentage: 10%Potential base bonus: $ 10,000 Step # 2: Split award target amount based on weighting of Performance FactorsPotential corporate performance bonus (40%):$ 4,000Potential individual performance bonus (60%):$ 6,000 Step # 3: Actual Cash Incentive Award CalculationAssumed payment multipliers based on assessment of corporate and individualperformance:Corporate multiplier 75% - performance generally met objectivesIndividual multiplier 125% - performance generally exceeded objectivesCash Award:Corporate component $ 3,000 ($4,000 x 75%)Individual component $ 7,500 ($6,000 x 125%)Total Award $ 10,500 AWARD PAYMENTSBonus award payments may be made in cash, through the issuance of stock, stock options or another form of equity award, or by acombination of cash, stock, stock options and/or another form of equity award, at the discretion of the Compensation Committee. Allbonus award payments are subject to applicable tax withholdings. In the event that the Compensation Committee and/or the Board ofDirectors elect to pay bonus awards in stock or stock options, the Compensation Committee, in its sole discretion, will make adetermination as to the number of shares of stock or stock options to be issued to each Plan participant based, in part, upon the overallcorporate performance and each participant’s individual performance, as described. The issuance of stock and stock options may alsobe subject to the approval of the Company’s stockholders, and any stock options issued will be subject to the terms and conditions ofthe Company’s equity incentive award plan, as amended from time to time by the Company. Payment of bonus awards will be made as soon as practicable after the issuance of the Company’s year-end audited FinancialStatements for the Plan year, but not later than December 31 of the year following the Plan year. Payments will not be impacted by anybenefits, with the exception of elected 401(k) contributions which will be applied. 3 PLAN PROVISIONSGovernanceThe Plan will be governed by the Compensation Committee. The President and/or CEO of Cidara will be responsible for theadministration of the Plan. The Compensation Committee will be responsible for recommending to the Board of Directors a bonusamount for the President and/or CEO (unless such compensation is intended to be qualified, performance-based compensation underSection 162(m) of the Internal Revenue Code of 1986, as amended). Additionally, the Compensation Committee will be responsible forapproving any compensation or incentive awards to other executive officers of the Company and all other officers who are subject tothe reporting requirements of Section 16(a) of the Securities Exchange Act of 1934, as amended. All determinations of theCompensation Committee, under the Plan, shall be final and binding on all Plan participants. Compensation Committee’s Absolute Right to Alter or Abolish the PlanThe Compensation Committee reserves the right in its absolute discretion to terminate the Plan, or any portion of the Plan, at any time orto alter the terms and conditions under which a bonus will be paid. In the event of the Plan’s termination prior to the payment of abonus, such bonus will not be payable under this Plan. Such discretion may be exercised any time before, during, and after the Planyear is completed. No participant shall have any vested right to receive any compensation hereunder until actual delivery of suchcompensation. Participation in the Plan at any given time does not guarantee ongoing participation. Employment Duration/Employment RelationshipThis Plan does not, and Cidara’s policies and practices in administering this Plan do not, constitute an express or implied contract orother agreement concerning the duration of any participant’s employment with the Company. The employment relationship of eachparticipant is “at will” and may be terminated at any time by Cidara or by the participant, with or without cause. Any questions pertaining to this Plan should be directed to the Human Resources Department.4 Exhibit 21.1Cidara Therapeutics, Inc. SubsidiariesThe following is a list of subsidiaries of the Company, doing business under the name stated.NameCountry or State of IncorporationCidara Therapeutics UK LimitedUnited Kingdom Exhibit 23.1Consent of Independent Registered Public Accounting FirmWe consent to the incorporation by reference in the Registration Statement (Form S-8 No. 333-203434) pertaining to the 2013 Stock Option andGrant Plan, 2015 Equity Incentive Plan, and 2015 Employee Stock Purchase Plan of Cidara Therapeutics, Inc. of our report dated March 17, 2016,with respect to the financial statements of Cidara Therapeutics, Inc., included in this Annual Report (Form 10-K) for the year ended December 31,2015./s/ Ernst & Young LLPSan Diego, CaliforniaMarch 17, 2016 Exhibit 31.1CERTIFICATION PURSUANT TORULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934,AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002I, Jeffrey Stein, Ph.D., certify that:1.I have reviewed this Annual Report on Form 10-K of Cidara Therapeutics, Inc.;2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary tomake the statements made, in light of the circumstances under which such statements were made, not misleading with respect to theperiod covered by this report;3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all materialrespects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;4.The registrant's other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (asdefined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the registrant and have: (a)Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under oursupervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known tous by others within those entities, particularly during the period in which this report is being prepared; (b)Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusionsabout the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on suchevaluation; and (c)Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant'smost recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or isreasonably likely to materially affect, the registrant's internal control over financial reporting; and5.The registrant's other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financialreporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalentfunctions): (a)All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which arereasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and (b)Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant'sinternal control over financial reporting. Date: March 17, 2016 By: /s/ Jeffrey Stein, Ph.D. Jeffrey Stein, Ph.D.President and Chief Executive Officer (Principal Executive Officer) Exhibit 31.2CERTIFICATION PURSUANT TORULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934,AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002I, Kevin Forrest, Ph.D., certify that:1.I have reviewed this Annual Report on Form 10-K of Cidara Therapeutics, Inc.;2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary tomake the statements made, in light of the circumstances under which such statements were made, not misleading with respect to theperiod covered by this report;3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all materialrespects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;4.The registrant's other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (asdefined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the registrant and have: (a)Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under oursupervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known tous by others within those entities, particularly during the period in which this report is being prepared; (b)Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusionsabout the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on suchevaluation; and (c)Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant'smost recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or isreasonably likely to materially affect, the registrant's internal control over financial reporting; and5.The registrant's other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financialreporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalentfunctions): (a)All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which arereasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and (b)Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant'sinternal control over financial reporting. Date: March 17, 2016 By: /s/ Kevin Forrest, Ph.D. Kevin Forrest, Ph.D.Chief Financial Officer and Chief Operating Officer (Principal Financial Officer) Exhibit 32.1CERTIFICATION PURSUANT TO18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TOSECTION 906 OF THE SARBANES-OXLEY ACT OF 2002In connection with the Annual Report on Form 10-K of Cidara Therapeutics, Inc. (the “Company”) for the period ending December 31, 2015as filed with the Securities and Exchange Commission on the date hereof and to which this certification is attached as an exhibit (the “Report”), Icertify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that: (1)The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and (2)The information contained in the Report fairly presents, in all material respects, the financial condition and result of operations ofthe Company. Date: March 17, 2016 By: /s/ Jeffrey Stein, Ph.D. Jeffrey Stein, Ph.D.President and Chief Executive Officer (Principal Executive Officer) Exhibit 32.2CERTIFICATION PURSUANT TO18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TOSECTION 906 OF THE SARBANES-OXLEY ACT OF 2002In connection with the Annual Report on Form 10-K of Cidara Therapeutics, Inc. (the “Company”) for the period ending December 31, 2015as filed with the Securities and Exchange Commission on the date hereof and to which this certification is attached as an exhibit (the “Report”), Icertify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that: (1)The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and (2)The information contained in the Report fairly presents, in all material respects, the financial condition and result of operations ofthe Company. Date: March 17, 2016 By: /s/ Kevin Forrest, Ph.D. Kevin Forrest, Ph.D.Chief Financial Officer and Chief OperatingOfficer (Principal Financial Officer)

Continue reading text version or see original annual report in PDF format above